DCK · Class II · 21 CFR 866.5270

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

Leading manufacturers include Kamiya Biomedical Co., E.I. Dupont DE Nemours & Co., Inc. and Syva Co..

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 Jul 14, 2017
VITROS Chemistry Products hsCRP Reagent
K160712
Ortho-Clinical Diagnostics
Chemistry · 486d
Cleared Sep 24, 2015
VITROS Chemistry Products CRP Slides
K152433
Ortho-Clinical Diagnostics
Immunology · 28d
Cleared Sep 21, 2012
DIAZYME HSCRP POC TEST KIT
K121558
Diazyme Laboratories
Chemistry · 115d
Cleared Apr 27, 2011
DIAZYME HS CRP ASSAY KIT / CALIBRATOR SET / CONTROL SET
K103557
Diazyme Laboratories
Chemistry · 146d
Cleared Apr 28, 2006
CRP-ADVANCE ASSAY, MODELS 250-20, 250-25
K060139
Diagnostic Chemicals , Ltd.
Chemistry · 99d
Cleared Feb 09, 2006
NANOPIA WIDE RANGE C-REACTIVE PROTEIN (CRP) REAGENT KIT
K052591
Clinical Data, Inc.
Chemistry · 141d
Cleared Oct 14, 2004
WIDE RANGE C-REACTIVE PROTEIN (WR CRP) ASSAY
K041155
Stanbio Laboratory
Immunology · 164d
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 Jun 06, 2003
WAKO CRP, CALIBRATOR AND WAKO CRP CALIBRATOR SET
K024280
Wako Chemicals USA, Inc.
Chemistry · 165d
Cleared Mar 18, 2003
VITROS CHEMISTRY PRODUCTS CRP SLIDE AND CALIBRATOR KIT 7
K030626
Ortho-Clinical Diagnostics, Inc.
Immunology · 19d
Cleared Feb 04, 2003
K-ASSAY C-REACTIVE PROTEIN (3), K-ASSAY CRP MULTI-CALIBRATOR D, K-ASSAY CRP MULTI-CALIBRATOR E, K-ASSAY CRP MULTI-CALIBR
K023828
Kamiya Biomedical Co.
Immunology · 78d
Cleared Dec 23, 2002
HEMOSIL C-REACTIVE PROTEIN - HIGH SENSITIVITY AND HIGH SENSITIVITY CONTROLS
K023269
Instrumentation Laboratory CO
Chemistry · 83d
Cleared Aug 14, 2002
K-ASSAY HS-CRP CONTROLS
K022486
Kamiya Biomedical Co.
Immunology · 16d
Cleared Jul 29, 2002
RAICHEM CRP HIGH SENSITIVITY TEST SYSTEM
K021194
Hemagen Diagnostics, Inc.
Chemistry · 105d
Cleared May 29, 2001
SYNCHRON LX SYSTEMS HIGH SENSITIVITY C-REACTIVE PROTIEN (CRPH) REAGENT
K010597
Beckman Coulter, Inc.
Chemistry · 90d
Cleared May 16, 2001
K-ASSAY HS-CRP CONTROLS
K011079
Kamiya Biomedical Co.
Immunology · 37d
Cleared Apr 05, 2001
IMMAGE IMMUNOCHEMISTRY SYSTEM HIGH SENSITIVITY C-REACTIVE PROTEIN (CRPH) REAGENT
K010236
Beckman Coulter, Inc.
Immunology · 70d
Cleared Oct 25, 2000
K-ASSAY HIGH SENSITIVE CRP(2) FOR THE BECKMAN COULTER IMMAGE
K002558
Kamiya Biomedical Co.
Immunology · 72d
Cleared Oct 13, 2000
C-REACTIVE PROTEIN (HIGH SENSITIVITY) REAGENT SET
K002651
Pointe Scientific, Inc.,
Chemistry · 49d

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 →