ClearanceBrief
Panels › Immunology › Product code DCK · Class 2

C-Reactive Protein, Antigen, Antiserum, And Control

Regulation 866.5270

0510(k)s in 12 months (126 all time)
0recalls in 12 months (17 all time)
16recalls that name a 510(k)
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Top companies in DCK

DateFirm and productCodeLinked 510(k)
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
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
Sep 30, 2024Randox Laboratories
CRP Immunoturbidimetric reagent. Intended for the quantitative in vitro determination of CRP concentration in serum Catalogue number: CP3826
Open, Classified
DCKK953212
Jun 26, 2017Medtest Holdings, Inc.
Pointe Scientific CRP(HS) Wide Range Control Set and Pointe Scientific CRP(HS) Wide Range Standard Set 5 Levels of 1 x 2 ml ready to use calibrator or standard The Pointe Scientific CRP (HS) Wide Ra
Terminated
DCKK030545
Oct 26, 2016Ortho-Clinical Diagnostics
VITROS CRP Slides: 1) VITROS Chemistry Products CRP Slides (250 slides per sales unit), Catalog # 1926740 and 2) , VITROS Chemistry Products CRP Slides (90 slides per sales unit), Catalog # 1926740
Terminated
DCKK152433
K953197
Nov 15, 2013Ortho-Clinical Diagnostics
VITROS Chemistry Products CRP Slides packaged as 90 slides/pack catalog number 8097990 VITROS CRP Slides quantitatively measure C-reactive protein (CRP) concentration in serum and plasma using VITROS
Terminated
DCKK030626
Jun 27, 2013Ortho-Clinical Diagnostics
VITROS Chemistry Products CRP Slides (Reagent), REF/Catalog Number 192 6740 and 809 7990, Product Usage: For in vitro diagnostic use only. VITROS Chemistry Products CRP Slides quantitatively measur
Terminated
DCKNone listed
Apr 25, 2013Alere San Diego, Inc.
The Alere Cholestech LDX high sensitivity C-Reactive Protein (hsCRP) Test Cassette, Model Number 12-807. Product Usage: Immunoassay for the determination of C-Reactive Protein (CRP). The Alere Ch
Terminated
DCKK040579
Mar 4, 2010Kamiya Biomedical Company, LLC
"K-ASSAY CRP (3) Calibrator E". This product is an IVD calibrator for use on automated clinical chemistry analyzers by laboratories. It is used for the calibration of the K-ASSAY CRP (3) immunoturbi
Terminated
DCKK023828
Mar 2, 2010Beckman Coulter Inc
IMMAGE Immunochemistry Systems C-Reactive Protein (CRP) Reagent, Part Number 447280. Intended for the quantitative determination of C-Reactive Protein (CRP) in human serum or plasma by rate nephelome
Terminated
DCKK981638
Sep 20, 2008Cholestech Corp
Cholestech LDX High Sensitivity C-Reactive Protein (hs-CRP) Test Cassette. The Cholestech LDX high sensitivity C-Reactive Protein (hs-CRP) is an in vitro diagnostic test for the quantitative determin
Terminated
DCKK040579
May 6, 2006Kamiya Biomedical Company
K-ASSAY CRP(2) Reagent. Kit is labeled K-ASSAY CRP (2) Latex Particle Enhance ITA. Kit contains 2 vials. One vial labeled K-ASSAY CRP(2) R-1 30 mL 170 mM Glycine Buffer, via has a white cap. The
Terminated
DCKK992312
Jan 8, 2005Ortho-Clinical Diagnostics
Vitros CRP (C-Reactive Protein) Slides. Catalog #192 6740 contains 250 slides; Catalog #809 7990 contains 90 slides. Firm on label: Ortho-Clinical Diagnostics, a Johnson & Johnson Company, Rocheste
Terminated
DCKK030626
Sep 18, 2004Ortho-Clinical Diagnostics
VITROS CRP Slides: (1) Cat # 192 6740, 250 slides per box, and (2) Cat # 809 7990, 90 slides per box. Firm on the label: Ortho-Clinical Diagnostics, Inc., Rochester, NY 14626. The CRP Slides are f
Terminated
DCKK030626
Feb 4, 2004Abbott Laboratories HPD/ADD/GPRD
TDx/TDxFLx C-Reactive Protein (CRP) Reagents, list 9550-60; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064
Terminated
DCKK854542
Jan 6, 2004Polymedco, Inc
POLYMEDCO ULTRA-CRP LATEX ENHANCED ASSAY, Catalog No. CPU400. Contents: 1 x 50 ML R1, 2 x 6 ML R2. R1 is the HIGH SENSITIVE CRP Buffer IVD (50 ml). R2 is the HIGH SENSITIVE CRP Latex IVD (6 ml). For
Terminated
DCKK001009
Jan 6, 2004Polymedco, Inc
POLYMEDCO ULTRA-CRP High Sensitive Assay For the DIMENSION(R) systems, Catalog No. USC300. Contents: 4 x 50 Tests. For In Vitro Diagnostic (IVD) use only. COMMON/USUAL NAME: High-Sensitive C-Reactiv
Terminated
DCKK001009

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