DCK · Class II · 21 CFR 866.5270

FDA Product Code DCK: C-reactive Protein, Antigen, Antiserum, And Control

Leading manufacturers include Syva Co., E.I. Dupont DE Nemours & Co., Inc. and Beckman Instruments, Inc..

126
Total
126
Cleared
94d
Avg days
1976
Since
Stable submission activity - 1 submissions in the last 2 years
Review times increasing: avg 268d recently vs 93d historically

FDA 510(k) Cleared C-reactive Protein, Antigen, Antiserum, And Control Devices (Product Code DCK)

126 devices
1–24 of 126
Cleared Apr 18, 2025
K-ASSAY CRP (Ver.2)
K242170
Kamiya Biomedical Company, LLC
Immunology · 268d
Cleared Nov 04, 2022
Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge
K201256
Procise Diagnostics
Immunology · 907d
Cleared Jun 25, 2020
Yumizen C1200 CRP
K192028
HORIBA ABX SAS
Immunology · 335d
Cleared Nov 08, 2019
CRP Vario
K192118
SENTINEL CH. SpA
Immunology · 94d
Cleared Oct 03, 2019
Yumizen C1200 CRP
K191993
HORIBA ABX SAS
Chemistry · 70d
Cleared Dec 19, 2003
QUANTEX CRP HIGH SENSITIVITY STANDARD MULTIPOINT, QUANTEX CRP HIGH SENSITIVITY CONTROLS VE CONTROLS 1/2
K032663
Instrumentation Laboratory CO
Chemistry · 113d
Cleared Dec 23, 2002
HEMOSIL C-REACTIVE PROTEIN - HIGH SENSITIVITY AND HIGH SENSITIVITY CONTROLS
K023269
Instrumentation Laboratory CO
Chemistry · 83d
Cleared May 29, 2001
SYNCHRON LX SYSTEMS HIGH SENSITIVITY C-REACTIVE PROTIEN (CRPH) REAGENT
K010597
Beckman Coulter, Inc.
Chemistry · 90d
Cleared Apr 05, 2001
IMMAGE IMMUNOCHEMISTRY SYSTEM HIGH SENSITIVITY C-REACTIVE PROTEIN (CRPH) REAGENT
K010236
Beckman Coulter, Inc.
Immunology · 70d
Cleared Oct 25, 1999
DADE BEHRING N HIGH SENSITIVITY CRP ASSAY
K991385
Dade Behring, Inc.
Immunology · 187d
Cleared May 03, 1999
ARRAY 360 SYSTEM C-REACTIVE PROTEIN (CRP MPE) REAGENT
K990704
Beckman Coulter, Inc.
Immunology · 60d
Cleared Apr 06, 1999
IMMULITE C-REACTIVE PROTEIN, MODEL LKCR1, LKCR5
K990886
Diagnostic Products Corp.
Immunology · 20d
Cleared Jan 28, 1999
IMMULITE C-REACTIVE PROTEIN, MODELS LKC1, LKC5
K984132
Diagnostic Products Corp.
Immunology · 71d
Cleared Aug 18, 1998
ROCHE CRP T CONTROL N
K982087
Roche Diagnostic Systems, Inc.
Immunology · 64d
Cleared Jun 12, 1998
IMMAGE IMMUNOCHEMISTRY SYSTEM C-REACTIVE PROTEIN (CRP) REAGENT
K981638
Beckman Coulter, Inc.
Immunology · 35d
Cleared Nov 24, 1997
SYNCHRON SYSTEMS C-REACTIVE PROTEIN (CRP) REAGENT
K974050
Beckman Instruments, Inc.
Immunology · 31d
Cleared Nov 04, 1996
IMMAGE IMMUNOCHEMISTRY SYSTEM C-REACTIVE PROTEIN (CRP) REAGENT
K963061
Beckman Instruments, Inc.
Immunology · 89d
Cleared Mar 10, 1993
TINA-QUANT CRP
K930621
Boehringer Mannheim Corp.
Immunology · 30d
Cleared Dec 07, 1992
VIGIL II
K920845
Beckman Instruments, Inc.
Microbiology · 286d
Cleared Oct 19, 1988
DU PONT DIMENSION C-REACTIVE PROTEIN CALIBRATOR
K884101
E.I. Dupont DE Nemours & Co., Inc.
Immunology · 63d
Cleared Mar 21, 1988
VISION(R) CRP
K875345
Abbott Laboratories
Immunology · 82d
Cleared Jun 15, 1987
TINA-QUANT [A] CRP
K871895
Boehringer Mannheim Corp.
Immunology · 31d
Cleared May 06, 1987
PRECIMAT(R) CRP
K871055
Boehringer Mannheim Corp.
Immunology · 50d
Cleared Mar 16, 1987
VISION(TM) CRP
K864131
Abbott Laboratories
Immunology · 146d

About Product Code DCK - Regulatory Context

510(k) Submission Activity

126 total 510(k) submissions under product code DCK since 1976, with 126 receiving FDA clearance (average review time: 94 days).

Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.

FDA 510(k) Review Time - DCK Product Code

Recent submissions under DCK have taken an average of 268 days to reach a decision - up from 93 days historically. Manufacturers should account for longer review timelines in current project planning.

DCK devices are reviewed by the Immunology panel. Browse all Immunology devices →