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Panels › Clinical Chemistry › Product code JJE · Class 1

Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

Regulation 862.2160

0510(k)s in 12 months (208 all time)
10recalls in 12 months (564 all time)
494recalls that name a 510(k)
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Top companies in JJE

DateFirm and productCodeLinked 510(k)
Jul 3, 2024Beckman Coulter, Inc.
DxI 9000 Access Immunoassay Analyzer, C11137; in-vitro diagnostic
Open, Classified
JJEK221225
Jun 28, 2024Beckman Coulter, Inc.
Beckman Coulter DxI 9000 Access Immunoassay Analyzer is a discrete photometric chemistry analyzer for clinical use. It is an in-vitro diagnostic device used for the quantitative, semi-quantitative, o
Open, Classified
JJENone listed
May 9, 2024Randox Laboratories Ltd.
Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative determination of parent drug molecule and metabolites of drugs in human urine Catalog Number: EV4115
Open, Classified
JJEK220451
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
Feb 5, 2024Beckman Coulter, Inc.
DxI 9000 Access Immunoassay Analyzer running software version 1.16 or prior,
Open, Classified
JJEK221225
Jan 9, 2024Abbott Laboratories
ARCHITECT c4000 Processing Module REF: 02P24-01 02P24-02 02P24-40 01R24-56 01R25-56 The Abbott ARCHITECT c4000 Processing Module is designed to perform automated chemistry tests, utilizing photometr
Open, Classified
JJENone listed
Jan 9, 2024Abbott Laboratories
Alinity c Processing Module REF 03R67-01 The Alinity c Processing Module is a fully automated chemistry analyzer allowing random and continuous access, as well as priority and automated retest proce
Open, Classified
JJENone listed
Jan 9, 2024Abbott Laboratories
Alinity i Processing Module REF 03R65-01 The Alinity i Processing Module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and automated retest pro
Open, Classified
JJENone listed
Dec 22, 2023Abbott Laboratories
Alinity ci-series System Control Module, REF: 03R70-01
Open, Classified
JJENone listed
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
Oct 12, 2023Beckman Coulter, Inc.
DxI 9000 Access Immunoassay Analyzer, REF C11137, Sofware Versions 1.15 and below; invitro diagnostic
Open, Classified
JJEK221225
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
Jul 26, 2023Beckman Coulter, Inc.
Ringed DxI Reaction Vessels (RVs)
Open, Classified
JJEK023764
Jul 14, 2023Beckman Coulter Biomedical GmbH
Beckman Coulter DxA Automation System, DxA 5000 Fit, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly
Open, Classified
JJEK190298
Jul 14, 2023Beckman Coulter Biomedical GmbH
Beckman Coulter DxA Automation System, DxA 5000, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly
Open, Classified
JJEK190298
Jul 5, 2023Siemens Healthcare Diagnostics, Inc.
Aptio Automation Storage and Retrieval Module (SRM)
Open, Classified
JJEK043546
May 4, 2023Ortho-Clinical Diagnostics, Inc.
VITROS 5600 Integrated System - Refurbished . For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistr
Open, Classified
JJEK081543
May 4, 2023Ortho-Clinical Diagnostics, Inc.
VITROS 5600 Integrated System- For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Micr
Open, Classified
JJEK081543
May 4, 2023Ortho-Clinical Diagnostics, Inc.
VITROS XT 7600 Integrated System - For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products
Open, Classified
JJEK182063
Mar 15, 2023Beckman Coulter, Inc.
Access Immunoassay Systems (1) Access 2 Immunoassay Analyzer (81600N); (2) Access 2 Immunoassay Analyzer, Refurbished (386220); (3) Access 2 Immunoassay Analyzer, Refurbished (A65531) ; and (4) Acces
Open, Classified
JJEK060256
K121214
Aug 26, 2022Mckesson Medical-Surgical Inc. Corporate Office
HORIBA ABX MEDICAL INC ABX PENTRA ETCHING CP System Fluid ABX Pentra Eching Solution CP For ABX Pentra 400 Clinical Chemistry Analyzer 25 mL. Ref: 1220001769
Open, Classified
JJENone listed
Jul 19, 2022Ortho-Clinical Diagnostics, Inc.
VITROS XT 7600 Integrated System with Version 3.7.2 and below Product Code: 6844461
Open, Classified
JJEK182063
Jul 19, 2022Ortho-Clinical Diagnostics, Inc.
VITROS XT 3400 Chemistry System with Version 3.7.2 and below Product Code: 6844458
Open, Classified
JJEK182063
Jul 14, 2022Roche Diagnostics Operations, Inc.
cobas e801 Immunoassay Analyzer
Open, Classified
JJENone listed
Oct 15, 2021Siemens Healthcare Diagnostics, Inc.
Dimension Vista 500- In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of anal
Terminated
JJEK051087
K143720
Oct 15, 2021Siemens Healthcare Diagnostics, Inc.
Dimension Vista 1500 In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of anal
Terminated
JJEK051087
K143720
Sep 29, 2021Abbott Laboratories
ARCHITECT c4000 REF 02P24-01/2P24, 1P86, 1R24, and 1R25; ARCHITECT c8000 REF 01G06-11/1G06; ARCHITECT c16000 REF 03L77-01/3L77;
Open, Classified
JJEK983212
Sep 29, 2021Abbott Laboratories
ARCHITECT i1000SR REF 01L86-01/1L86 and 1L87; ARCHITECT i2000SR REF 03M74-02/3M74; ARCHITECT i2000 REF 08C89-01/1G17 and 8C89
Open, Classified
JJEK983212
Sep 28, 2021Siemens Healthcare Diagnostics, Inc
Atellica IM 1600 Analyzer, SMN 11066000
Open, Classified
JJEK151792
Sep 28, 2021Siemens Healthcare Diagnostics, Inc
Atellica IM 1300 Analyzer, SMN 11066001
Open, Classified
JJEK151792
Jul 26, 2021Abbott Laboratories
Alinity ci-series System Control Module clinical chemistry and immunoassay analyzer for in vitro diagnostic use. Model number LN 03R70-01
Open, Classified
JJENone listed
Jul 21, 2021Beckman Coulter Inc.
DxA 5000 (DxA Automation System, DxA 5000 fit), "For in Vitro Diagnostic Use", Reference Numbers: B87352 with B57634, UDI: 15099590707118
Terminated
JJEK190298
Apr 26, 2021Roche Diagnostics Operations, Inc.
IRON GEN 2: ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES, Catalog#: 03183696122 - Product Usage: In vitro test for the quantitative determination of iron in human serum and plasma on Roche/Hitachi
Open, Classified
JJEK951595
Jan 7, 2021Ortho-Clinical Diagnostics, Inc.
VITROS Automation Solutions, VAS, Catalog Numbers 6844300 & 6844301 - Product Usage: intended to automate pre-analytical and post-analytical sample processing in the clinical laboratory.
Terminated
JJENone listed

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