FDA 510(k) Applications for Medical Device Product Code "DCK"
(C-Reactive Protein, Antigen, Antiserum, And Control)

FDA 510(k) Number Applicant Device Name Decision Date
K990704 BECKMAN COULTER, INC. ARRAY 360 SYSTEM C-REACTIVE PROTEIN (CRP MPE) REAGENT 05/03/1999
K981638 BECKMAN COULTER, INC. IMMAGE IMMUNOCHEMISTRY SYSTEM C-REACTIVE PROTEIN (CRP) REAGENT 06/12/1998
K010236 BECKMAN COULTER, INC. IMMAGE IMMUNOCHEMISTRY SYSTEM HIGH SENSITIVITY C-REACTIVE PROTEIN (CRPH) REAGENT 04/05/2001
K010597 BECKMAN COULTER, INC. SYNCHRON LX SYSTEMS HIGH SENSITIVITY C-REACTIVE PROTIEN (CRPH) REAGENT 05/29/2001
K963061 BECKMAN INSTRUMENTS, INC. IMMAGE IMMUNOCHEMISTRY SYSTEM C-REACTIVE PROTEIN (CRP) REAGENT 11/04/1996
K974050 BECKMAN INSTRUMENTS, INC. SYNCHRON SYSTEMS C-REACTIVE PROTEIN (CRP) REAGENT 11/24/1997
K962523 BEHRING DIAGNOSTICS, INC. N LATEX CRP MONO REAGENT 07/10/1996
K962373 BEHRING DIAGNOSTICS, INC. N/T RHEUMATOLOGY CONTROL SL/1 AND SL/2 07/11/1996
K003851 BIOCHECK, INC. BIOCHECK HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1119 07/20/2001
K040579 CHOLESTECH CORP. CHOLETECH LDX HIGH-SENSITIVITY C-REACTIVE PROTEIN (HS-CRP) 06/18/2004
K052591 CLINICAL DATA, INC. NANOPIA WIDE RANGE C-REACTIVE PROTEIN (CRP) REAGENT KIT 02/09/2006
K961829 CONSOLIDATED TECHNOLOGIES, INC. QUALITROL CRP CONTROL SET 08/19/1996
K965110 CRESTAT DIAGNOSTICS, INC. N-ASSAY TIA MULTI CRP CALIBRATOR SET 07/03/1997
K991385 DADE BEHRING, INC. DADE BEHRING N HIGH SENSITIVITY CRP ASSAY 10/25/1999
K030545 DENKA SEIKEN CO., LTD. CRP-LATEX (II)X2 SEIKEN ASSAY KIT 06/02/2003
K060139 DIAGNOSTIC CHEMICALS LTD. CRP-ADVANCE ASSAY, MODELS 250-20, 250-25 04/28/2006
K990886 DIAGNOSTIC PRODUCTS CORP. IMMULITE C-REACTIVE PROTEIN, MODEL LKCR1, LKCR5 04/06/1999
K984132 DIAGNOSTIC PRODUCTS CORP. IMMULITE C-REACTIVE PROTEIN, MODELS LKC1, LKC5 01/28/1999
K981871 DIAGNOSTIC SYSTEMS LABORATORIES, INC. C-REACTIVE PROTEIN ELISA, MODEL NUMBER DSL-10-42100 11/09/1998
K103557 DIAZYME LABORATORIES DIAZYME HS CRP ASSAY KIT / CALIBRATOR SET / CONTROL SET 04/27/2011
K121558 DIAZYME LABORATORIES DIAZYME HSCRP POC TEST KIT 09/21/2012
K040241 GENZYME CORP. N-GENEOUS WIDE RANGE CRP REAGENT AND CALIBRATOR SET 06/25/2004
K960702 GLOBE MANAGEMENT SUPPORT, INC. CRP-LATEX SEIKEN XR REAGENT SYSTEM 04/19/1996
K960324 HEMAGEN DIAGNOSTICS, INC. HEMAGEN CRP 150 KIT (EIA METHOD) 03/12/1996
K021194 HEMAGEN DIAGNOSTICS, INC. RAICHEM CRP HIGH SENSITIVITY TEST SYSTEM 07/29/2002
K061138 HORIBA ABX ABX PENTRA 400 : CRP 09/29/2006
K191993 Horiba ABX SAS Yumizen C1200 CRP 10/03/2019
K192028 Horiba ABX SAS Yumizen C1200 CRP 06/25/2020
K023269 INSTRUMENTATION LABORATORY CO. HEMOSIL C-REACTIVE PROTEIN - HIGH SENSITIVITY AND HIGH SENSITIVITY CONTROLS 12/23/2002
K032663 INSTRUMENTATION LABORATORY CO. QUANTEX CRP HIGH SENSITIVITY STANDARD MULTIPOINT, QUANTEX CRP HIGH SENSITIVITY CONTROLS VE CONTROLS 1/2 12/19/2003
K023828 KAMIYA BIOMEDICAL CO. K-ASSAY C-REACTIVE PROTEIN (3), K-ASSAY CRP MULTI-CALIBRATOR D, K-ASSAY CRP MULTI-CALIBRATOR E, K-ASSAY CRP MULTI-CALIBR 02/04/2003
K991224 KAMIYA BIOMEDICAL CO. K-ASSAY CRP 05/14/1999
K992312 KAMIYA BIOMEDICAL CO. K-ASSAY CRP (2), K-ASSAY CRP MULTI-CALIBRATOR A, K-ASSAY CRP MULTI-CALIBRATOR B 09/13/1999
K991210 KAMIYA BIOMEDICAL CO. K-ASSAY CRP CALIBRATOR SET 05/11/1999
K992311 KAMIYA BIOMEDICAL CO. K-ASSAY CRP(1), K-ASSAY CRP MULTI-CALIBRATOR A, K-ASSAY CRP MULTI-CALIBRATORC 09/13/1999
K002558 KAMIYA BIOMEDICAL CO. K-ASSAY HIGH SENSITIVE CRP(2) FOR THE BECKMAN COULTER IMMAGE 10/25/2000
K011079 KAMIYA BIOMEDICAL CO. K-ASSAY HS-CRP CONTROLS 05/16/2001
K022486 KAMIYA BIOMEDICAL CO. K-ASSAY HS-CRP CONTROLS 08/14/2002
K042442 ORION DIAGNOSTICA OY QUICKREAD SYSTEM: QUICKREAD CRP KIT, MODEL 06085; QUICKREAD 101 INSTRUMENT, MODEL 06088; QUICKREAD CRP CONTROL SET, MODE 09/24/2004
K142993 ORION DIAGNOSTICA OY QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument 03/10/2016
K031607 ORION DIAGNOSTICA, DIV. ORION CORP. ORION DIAGNOSTICA QUIKREAD CRP KIT AND QUIKREAD CRP CONTROL 10/10/2003
K022176 ORION DIAGNOSTICA, DIV. ORION CORP. ORION DIAGNOSTICA ULTRASENSITIVE CRP KIT, MODEL 68025, & ORION DIAGNOSTICA ULTRASENSITIVE CRP CONTROL, MODEL 68257 12/03/2002
K152433 ORTHO CLINICAL DIAGNOSTICS VITROS Chemistry Products CRP Slides; VITRO Chemistry Products Calibrator Kit 7 09/24/2015
K160712 Ortho Clinical Diagnostics VITROS Chemistry Products hsCRP Reagent 07/14/2017
K030626 Ortho-Clinical Diagnostics, Inc. VITROS CHEMISTRY PRODUCTS CRP SLIDE AND CALIBRATOR KIT 7 03/18/2003
K002651 POINTE SCIENTIFIC, INC. C-REACTIVE PROTEIN (HIGH SENSITIVITY) REAGENT SET 10/13/2000
K962049 POLYMEDCO, INC. C-REACTIVE PROTEIN (CRP) AGGLUTINATION LATEX KIT 12/18/1996
K013787 PRIMUS CORP. NYCOCARD CRP 05/14/2002
K014084 PRIMUS CORP. NYCOCARD CRP CONTROL 01/07/2002
K201256 Procise Diagnostics Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge 11/04/2022
K141689 Qualigen, Inc. FastPack High Sensitivity C-Reactive Protein Immunoassay, High Sensitivity C-Reactive Protein Calibrator Kit, FastPack High Sensitivity C-Reactive Protein Controls, FastPack High Sensitivity C-Reactive Protein Method Verification Kit 01/07/2015
K001009 RANDOX LABORATORIES, LTD. RANDOX C-REACTIVE PROTEIN 08/04/2000
K030044 REFERENCE DIAGNOSTICS, INC. EXTENDED RANGE HS CRP KIT, CAT NO:9200 09/30/2003
K021609 REFERENCE DIAGNOSTICS, INC. RDI HS CRP KIT 06/27/2002
K982087 ROCHE DIAGNOSTIC SYSTEMS, INC. ROCHE CRP T CONTROL N 08/18/1998
K192118 Sentinel CH, Spa CRP Vario 11/08/2019
K050836 SENTINEL CH. SRL CRP DIAGNOSTIC ASSAY 08/08/2005
K041155 STANBIO LABORATORY WIDE RANGE C-REACTIVE PROTEIN (WR CRP) ASSAY 10/14/2004
K962019 TECO DIAGNOSTICS C-REACTIVE PROTEIN (CRP):A LATEX SLIDE TEST 11/25/1996
K001636 THE BINDING SITE, LTD. C-REACTIVE PROTEIN ANTISERUM KIT 08/24/2000
K972160 TRINITY LABORATORIES, INC. CRP-LEX SYSTEM: C-REACTIVE PROTEIN ANTIGEN DETECTION IN SERUM: SLIDE AGGLUTNATION LATEX TEST 08/01/1997
K973692 UNITED BIOTECH, INC. UBI MAGIWEL C-REACTIVE PROTEIN(CRP) QUANTITATIVE 02/09/1998
K955156 WAKO CHEMICALS, USA, INC. WAKO AUTOKIT CRP NEW 02/16/1996
K024280 WAKO CHEMICALS, USA, INC. WAKO CRP, CALIBRATOR AND WAKO CRP CALIBRATOR SET 06/06/2003


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