ClearanceBrief
Company · US

Ortho-Clinical Diagnostics

FDA 510(k) clearances and medical device recalls filed under this name, 1997 to 2025. Name variants (Inc, Corp, punctuation) are merged.

144510(k) clearances (0 in 12 months)
354recalls (0 in 12 months)
287recalls that name a 510(k)

Product codes

CodeDeviceRecords
JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use131
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)16
JIXCalibrator, Multi-Analyte Mixture15
JITCalibrator, Secondary12
DCKC-Reactive Protein, Antigen, Antiserum, And Control10
MMIImmunoassay Method, Troponin Subunit10
JFYEnzymatic Method, Creatinine9
JJYMulti-Analyte Controls, All Kinds (Assayed)9
CGAGlucose Oxidase, Glucose8
LOMTest, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)8
CGZElectrode, Ion-Specific, Chloride7
CIGDiazo Colorimetry, Bilirubin7
DIFDrug Mixture Control Materials6
JGSElectrode, Ion Specific, Sodium6
JLWRadioimmunoassay, Thyroid-Stimulating Hormone6
CIWStarch-Dye Bound Polymer, Amylase5
CJYAzo Dye, Calcium5
DIHColorimetry, Cholinesterase5
DIPEnzyme Immunoassay, Diphenylhydantoin5
DLZEnzyme Immunoassay, Phenobarbital5

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Oct 29, 2025K252393VITROS Immunodiagnostic Products hs Troponin I Reagent Pack
Ortho-Clinical Diagnostics, Inc.
MMI
Aug 28, 2024K241534VITROS Immunodiagnostic Products Syphilis Reagent Pack
Ortho Clinical Diagnostics, GB
LIP
May 8, 2024K233581VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack
Ortho Clinical Diagnostics, GB
DHA
Sep 5, 2023K221197VITROS Immunodiagnostic Products Intact PTH II Reagent Pack
Ortho Clinical Diagnostics, GB
CEW
Aug 23, 2023K231517VITROS Immunodiagnostic Products CEA Reagent Pack
Ortho Clinical Diagnostics, GB
DHX
Aug 9, 2023K231525VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack
Ortho Clinical Diagnostics, GB
NIG
May 5, 2023DEN210040VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 To
Ortho-Clinical Diagnostics, Inc.
QVP
May 5, 2023DEN210038VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG
Ortho-Clinical Diagnostics, Inc.
QVP
Dec 12, 2022K221355VITROS Immuodiagnostic Products CA 125 II Reagent Pack
Ortho Clinical Diagnostics, GB
LTK
Jun 15, 2022K213626VITROS AFP
Ortho Clinical Diagnostics, GB
LOJ
Jan 28, 2022K212648VITROS Immunodiagnostic Products CK-MB Reagent Pack
Ortho Clinical Diagnostics, GB
JHX
Oct 4, 2021K201312VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack
Ortho Clinical Diagnostics
NBC
Aug 13, 2021K210858VITROS Chemistry Products PHBR Slides
Ortho-Clinical Diagnostics, Inc.
DLZ
Feb 25, 2020K200236VITROS BRAHMS PCT Reagent Pack and Calibrators
Ortho Clinical Diagnostics
PMT
Jun 7, 2019K191316VITROS XT Chemistry Products ALB-TP Slides
Ortho-Clinical Diagnostics, Inc.
CIX
Apr 26, 2019K190807VITROS XT Chemistry Products TBIL-ALKP Slides
Ortho-Clinical Diagnostics, Inc.
CIG
Apr 3, 2019K190520VITROS XT Chemistry Products GLU-Ca Slides
Ortho-Clinical Diagnostics, Inc.
CGA
Mar 27, 2019K190490VITROS XT Chemistry Products TRIG-CHOL Slides
Ortho-Clinical Diagnostics, Inc.
CHH
Mar 14, 2019K190326VITROS XT Chemistry Products UREA-CREA Slides
Ortho-Clinical Diagnostics, Inc.
CDN
Oct 30, 2018K182072VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS Chemistry Products GLU Slides
Ortho-Clinical Diagnostics, Inc.
CGZ
Oct 30, 2018K182063VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VIT
Ortho-Clinical Diagnostics, Inc.
JFY
Sep 18, 2017K163433VITROS Chemistry Products GLU Slides
Ortho Clinical Diagnostics
CGA
Jul 14, 2017K160712VITROS Chemistry Products hsCRP Reagent
Ortho Clinical Diagnostics
DCK
May 16, 2017K171168VITROS Immunodiagnostic Products Insulin Calibrators
Ortho Clinical Diagnostics
JIT
Dec 16, 2016K162020VITROS Chemistry Products Cl- Slides
Ortho Clinical Diagnostics
CGZ
Oct 18, 2016K160495VITROS® Automation Solutions
Ortho-Clinical Diagnostics, Inc.
KLI
May 20, 2016K161140VITROS Chemistry Products Calibrator Kit 3
Ortho-Clinical Diagnostics, Inc.
JIX
Sep 24, 2015K152433VITROS Chemistry Products CRP Slides; VITRO Chemistry Products Calibrator Kit 7
Ortho Clinical Diagnostics
DCK
Jun 4, 2015K142595VITROS Chemistry Products HbA 1c Reagent Kit, VITROS Calibrator Kit 31, VITROS Chemistry Products %A1c Performance Verif
Ortho Clinical Diagnostics
PDJ
May 31, 2013K130332VITROS CHEMISTRY PRODUCTS TRIG SLIDES
Ortho-Clinical Diagnostics, Inc.
CDT
May 15, 2013K123930VITROS CHEMISTRY PRODUCTS HCY 2 REAGENT, CALIBRATOR KIT 27, HCY 2 PERFORMANCE VERIFIERS I, II AND III
Ortho-Clinical Diagnostics, Inc.
LPS
Feb 15, 2013K121608VITROS IMMUNODIAGNOSTIC PRODUCTS 25-OH VITAMIN D TOTAL REAGENT PACK, VITAMIN D TOTAL CALIBRATORS
Ortho-Clinical Diagnostics, Inc.
MRG
Oct 24, 2012K120765VITROS CHEMISTRY PRODUCTS ECO2 SLIDES
Ortho-Clinical Diagnostics, Inc.
KHS
Sep 7, 2012K120609VITROS CHEMISTRY PRODUCTS DHDL SLIDES
Ortho-Clinical Diagnostics, Inc.
LBS
Oct 22, 2010K101921VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH REAGENT PACK, VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH CALIBRATORS, VIT
Ortho-Clinical Diagnostics
CEW
Apr 15, 2010K093611VITROS CHEMISTRY PRODUCTS CO2 DT SLIDES; VITROS CHEMMISTRY PRODUCTS DT CALIBRATOR KIT, MODELS CO2 DT SLIDES, 172 0002;
Ortho-Clinical Diagnostics, Inc.
KHS
Sep 3, 2009K091861VITROS CHEMISTRY PRODUCTS NA + DT SLIDES, MODEL 153 2290 AND DT CALIBRATOR KIT, MODEL 195 7927
Ortho-Clinical Diagnostics, Inc.
JGS
Apr 15, 2009K072732ORTHO T. CRUZI ELISA TEST SYSTEM
Ortho-Clinical Diagnostics, Inc.
MIU
Feb 27, 2009K083680VITROS CHEMISTRY PRODUCTS K+DT SLIDES: VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL K+DT SLIDES: 153 2258
Ortho-Clinical Diagnostics, Inc.
CEM
Dec 22, 2008K083173VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 3600 IMMUNODIAGNOSTIC SYSTEM
Ortho-Clinical Diagnostics
JLW
Oct 23, 2008K081543VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 5600 INTEGRATED SYSTEM
Ortho-Clinical Diagnostics, Inc.
JLW
Aug 21, 2008K082099VITROS CHEMISTRY PRODUCTS CI-DT SLIDES; VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODELS CI-DT SLIDES:131 4905
Ortho-Clinical Diagnostics, Inc.
CGZ
Jun 30, 2008K081411VITROS CHEMISTRY PRODUCT NA+ SLIDES; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2
Ortho-Clinical Diagnostics, Inc.
JGS
Dec 7, 2007K073157VITROS CHEMISTRY PRODUCTS K+ SLIDES AND CALIBRATOR KIT 2
Ortho-Clinical Diagnostics, Inc.
CEM
Sep 24, 2007K072443VITROS CHEMISTRY PRODUCTS CA DT SLIDES AND DT CALIBRATOR KIT AND VITROS CA ASSAY
Ortho-Clinical Diagnostics, Inc.
CJY
Sep 20, 2007K072440VITROS CHEMISTRY PRODUCTS: CA SLIDES (MODEL: 145 0261), CALIBRATORS KIT 1 (MODEL: 188 2208)
Ortho-Clinical Diagnostics, Inc.
CJY
Jul 20, 2007K071801VITROS CHEMISTRY PRODUCTS CI-SLIDES, CALIBRATOR KIT 2, MODEL(S) 844-5207, 166-2659
Ortho-Clinical Diagnostics, Inc.
JIX
May 25, 2007K071216VITROS CHEMISTRY PRODUCTS CRSC SLIDES, VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL 680 2721, 195 7927
Ortho-Clinical Diagnostics, Inc.
JFY
May 25, 2007K071215VITROS CHEMISTRY PRODUCTS URCR SLIDES, VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL 680 2722, 195 7927
Ortho-Clinical Diagnostics, Inc.
JFY
Apr 9, 2007K063720VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL B-HCG II REAGENT PACK, CALIBRATORS, RANGE VERIFIERS
Ortho-Clinical Diagnostics
DHA

Newest 50 of 144.

Latest recalls

DateFirm and productCodeLinked 510(k)
Sep 12, 2025Ortho-Clinical Diagnostics, Inc.
VITROS Chemistry Products LAC Slides. Catalog Number: 8150112. 1 Sales Unit = contains 5 cartridges of 18 slides, for a total of 90 tests.
Open, Classified
KHPK955286
Sep 12, 2025Ortho-Clinical Diagnostics, Inc.
Chemistry Products LAC Slides. Catalog Number: 8433880. 1 Sales Unit = contains 5 cartridges of 60 slides, for a total of 300 tests.
Open, Classified
KHPK955286
Aug 15, 2025Ortho-Clinical Diagnostics, Inc.
VITROS Chemistry Products Ca Slides; Catalog Number: 145 0261;
Open, Classified
CJYK072440
Jul 17, 2025Ortho-Clinical Diagnostics, Inc.
VITROS Chemistry Products CHE Slides (Japan); Catalog Numbers: (1) 684 4074 (90 slides), (2) 684 4138 (300 slides);
Open, Classified
DIHNone listed
Jul 17, 2025Ortho-Clinical Diagnostics, Inc.
VITROS Chemistry Products CHE Slides; Catalog Numbers: (1) 191 4605 (300 slides), (2) 800 4707 (90 slides);
Open, Classified
DIHNone listed
Jul 17, 2025Ortho-Clinical Diagnostics, Inc.
Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier II Model/Catalog Number: 8231474 Software Version: N/A Product Description: VITROS Chemistry Products
Open, Classified
DIHNone listed
Jul 17, 2025Ortho-Clinical Diagnostics, Inc.
Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier I Model/Catalog Number: 806 7324 Software Version: Not Applicable Product Description: VITROS Chemist
Open, Classified
DIHNone listed
Jul 2, 2025Ortho-Clinical Diagnostics, Inc.
VITROS Chemistry Products OP Reagent Gen 15. Model Number: 680 1997. The VITROS OP Reagent is a dual-chambered package containing ready-to-use liquid reagents that are used to detect opiates in urine.
Open, Classified
DJGK062460
Jun 27, 2025Ortho-Clinical Diagnostics, Inc.
Brand Name: VITROS Product Name: VITROS 4600 Chemistry System Model/Catalog Number: (1) 6802445, (2) 6900440 Software Version: version 3.2 to version 3.8.3 (all available software versions) Product De
Open, Classified
JJEK031924
Jun 27, 2025Ortho-Clinical Diagnostics, Inc.
Brand Name: VITROS; Product Name: VITROS XT 7600 Integrated System; Model/Catalog Number: (1) 6844461, (2) 6272222; Software Version: version 3.2 to version 3.8.3 (all available software versions); Pr
Open, Classified
JJEK182063
Jun 27, 2025Ortho-Clinical Diagnostics, Inc.
Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: (1) 6802413, (2) 6802915
Open, Classified
JJEK081543
Jun 11, 2025Ortho-Clinical Diagnostics, Inc.
Brand Name: Solana Bordetella Complete Assay Product Name: Solana Bordetella kit Model/Catalog Number: M308 Software Version: not applicable Product Description: One sales unit (kit) contains material
Open, Classified
OZZK181029
May 29, 2025Ortho-Clinical Diagnostics, Inc.
VITROS Chemistry Products CRP Slides. One sales unit contains 5 cartridges, of 18 slides per cartridge, for a total of 90 slides.
Open, Classified
DCKK152433
K953197
Jan 21, 2025Ortho-Clinical Diagnostics, INc.
Brand Name: VITROS Product Name: VITROS 3600 Immunodiagnostic System Model/Catalog Number: 6802783 (New), 6802914 (Certified/Refurbished), 6904000 (China) Software Version: version 3.8.0 or higher Pro
Open, Classified
JJEK083173
Jan 21, 2025Ortho-Clinical Diagnostics, INc.
Brand Name: VITROS Product Name: VITROS XT 7600 Integrated System Model/Catalog Number: 6844461 (New), 6272222 (Certified), 6904003 (China) Software Version: version 3.8.0 or higher Product Descriptio
Open, Classified
JJEK182063
Jan 21, 2025Ortho-Clinical Diagnostics, INc.
Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: 6802413 (New), 6802415 (Certified/Refurbished), 6904001 (China) Software Version: version 3.8.0 or higher Product D
Open, Classified
JJEK081543
Nov 25, 2024Ortho-Clinical Diagnostics, Inc.
VITROS Chemistry Products CRP Slides- In vitro diagnostic quantitatively measures C-reactive protein (CRP) concentration in serum and plasma Model/Catalog Number: 1926740
Open, Classified
DCKK152433
K953197
Aug 16, 2024Ortho-Clinical Diagnostics, Inc.
The VITROS XT Chemistry Products ALB-TP Slides is a single device that contains both an albumin test and a total protein test side by side separated by a plastic barrier sealed within a single slide f
Open, Classified
CIXNone listed
Aug 12, 2024Ortho-Clinical Diagnostics, Inc.
VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2
Open, Classified
CGNK001266
K984166
Jul 3, 2024Ortho-Clinical Diagnostics, Inc.
VITROS Chemistry Products FS Diluent Pack 3, Model/Catalog Number: 6801754. Product Description: VITROS Chemistry Products FS Diluent Pack 3 comes with 3 packs per sales unit.
Open, Classified
PPMNone listed
Jul 1, 2024Ortho-Clinical Diagnostics, Inc.
VITROS Chemistry Products Calibrator Kit 29- In-Vitor used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of tota
Open, Classified
JMONone listed
Jun 13, 2024Ortho-Clinical Diagnostics, Inc.
VITROS Immunodiagnostic Products Anti HBs Calibrators. The VITROS Anti-HBs Calibrator Pack contains 3 X labelled Calibrator tube (1 per level: C1 - green, C2 - yellow, C3 - red).
Open, Classified
LOMNone listed
Jun 4, 2024Ortho-Clinical Diagnostics, Inc.
VITROS Immunodiagnostic Products Vitamin B12 Range Verifier - In vitro diagnostic use ly. For use in verifying the calibration range of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS
Open, Classified
JJXNone listed
Mar 22, 2024Ortho-Clinical Diagnostics
VITROS Performance Verifier II
Open, Classified
JJYNone listed
Mar 22, 2024Ortho-Clinical Diagnostics
VITROS Performance Verifier I
Open, Classified
JJYNone listed
Mar 1, 2024Ortho-Clinical Diagnostics, Inc.
VITROS XT 7600 Integrated System, Catalog No. 6844461
Open, Classified
JJEK182063
Mar 1, 2024Ortho-Clinical Diagnostics, Inc.
VITROS XT 3400 Chemistry System, Catalog No. 6844458
Open, Classified
JJEK182063
Mar 1, 2024Ortho-Clinical Diagnostics, Inc.
VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished)
Open, Classified
JJEK081543
Mar 1, 2024Ortho-Clinical Diagnostics, Inc.
VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished)
Open, Classified
JJEK031924
Mar 1, 2024Ortho-Clinical Diagnostics, Inc.
VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)
Open, Classified
JJEK083173
Mar 1, 2024Ortho-Clinical Diagnostics, Inc.
VITROS XT 7600 Integrated System, Catalog No. 6844461
Open, Classified
JJEK182063
Mar 1, 2024Ortho-Clinical Diagnostics, Inc.
VITROS XT 3400 Chemistry System, Catalog No. 6844458
Open, Classified
JJEK182063
Mar 1, 2024Ortho-Clinical Diagnostics, Inc.
VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished)
Open, Classified
JJEK081543
Mar 1, 2024Ortho-Clinical Diagnostics, Inc.
VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished)
Open, Classified
JJEK031924
Mar 1, 2024Ortho-Clinical Diagnostics, Inc.
VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)
Open, Classified
JJEK083173
Mar 1, 2024Ortho-Clinical Diagnostics, Inc.
VITROS XT7600 Integrated System
Open, Classified
JJEK182063
Mar 1, 2024Ortho-Clinical Diagnostics, Inc.
VITROS 5600 Integrated System (New and Refurbished)
Open, Classified
JJEK081543
Mar 1, 2024Ortho-Clinical Diagnostics, Inc.
VITROS 3600 Immunodiagnostic System (New and Refurbished)
Open, Classified
JJEK083173
Jan 19, 2024Ortho-Clinical Diagnostics, Inc.
VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog No. 6801925 VITROS Immunodiagnostic Products Anti-HBs Calibrators, Catalog No. 6801926
Open, Classified
LOMNone listed
Jan 11, 2024Ortho-Clinical Diagnostics, Inc.
QMS Tacrolimus Calibrators, Product code 10015573
Open, Classified
JITK123343
Dec 13, 2023Ortho-Clinical Diagnostics, Inc.
VITROS XT 7600 Integrated System Product Code 6844461 Running Software Version 3.8.0
Open, Classified
JJEK182063
Dec 13, 2023Ortho-Clinical Diagnostics, Inc.
VITROS XT 3400 Chemistry System Product Code 6844458 Running Software Version 3.8.0
Open, Classified
JJEK182063
Dec 13, 2023Ortho-Clinical Diagnostics, Inc.
VITROS 5600 Integrated System Product Code 6802413 and Refurbished Product Code 6802915 Running Software Version 3.8.0
Open, Classified
JJEK081543
Dec 13, 2023Ortho-Clinical Diagnostics, Inc.
VITROS 4600 Chemistry System Product Code 6802445 and Refurbished Product Code 6900440 Running Software Version 3.8.0
Open, Classified
JJEK031924
Dec 13, 2023Ortho-Clinical Diagnostics, Inc.
VITROS 3600 Immunodiagnostic System Product Code 6802783 and Refurbished Product Code 6802914 Running Software Version 3.8.0
Open, Classified
JJEK083173
Dec 7, 2023Ortho-Clinical Diagnostics, INc.
VITROS Chemistry Products ECO2 Slides-For in vitro diagnostic use only. VITROS Chemistry Products ECO2 Slides quantitatively measure total carbon dioxide (CO2) concentration in serum and plasma using
Open, Classified
KHSK182072
Nov 6, 2023Ortho-Clinical Diagnostics, INc.
VITROS Chemistry Products Lipase Slides, Product Codes 1668409 (contains 60 Slides per Cartridge) and 8297749 (contains 18 slides per cartridge)
Open, Classified
CHINone listed
Oct 2, 2023Ortho-Clinical Diagnostics, Inc.
Proboscis/Piston Assembly, Part Number J55375, for VITROS 5,1 FS Chemistry System (Product Code 6801375), VITROS 5,1 Chemistry System (Refurbished) (Product Code 6801890), VITROS 3600 Immunodiagnostic
Open, Classified
JJEK031924
K081543 +2
Sep 21, 2023Ortho-Clinical Diagnostics, INc.
VITROS XT Chemistry Products ALKP Slides
Open, Classified
CJEK946090
Sep 21, 2023Ortho-Clinical Diagnostics, INc.
VITROS XT Chemistry Products TBIL-ALKP Slides
Open, Classified
CIGK190807

Newest 50 of 354.

Get alerts for these product codes