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
K854542 ABBOTT LABORATORIES TDX C-REACTIVE PROTEIN 01/24/1986
K875345 ABBOTT LABORATORIES VISION(R) CRP 03/21/1988
K864131 ABBOTT LABORATORIES VISION(TM) CRP 03/16/1987
K892146 AMPCOR, INC. C REACTIVE PROTEIN LIQUID 04/14/1989
K892119 AMPCOR, INC. QUIK-DOT C REACTIVE PROTEIN 04/14/1989
K882998 AMTEC DIAGNOSTICS INTERNATIONAL, INC. ACUTE PHASE C-REACTIVE PROTEIN LATEX AGGLU. TEST 09/07/1988
K850590 APPLICATIONS LAB SPQ TEST SYSTEM FOR C-REACTIVE PROTEIN 03/01/1985
K851842 ATLANTIC ANTIBODIES SPQ TEST SYSTEM FOR C-REACTIVE PROTEIN 06/05/1985
K892526 ATLANTIC ANTIBODIES SPQ TM TEST SYSTEM II FOR CRP 05/09/1989
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
K791650 BECKMAN INSTRUMENTS, INC. HUMAN, C-REACTIVE PROTEIN (CRP) 09/17/1979
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
K920845 BECKMAN INSTRUMENTS, INC. VIGIL II 12/07/1992
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
K944375 BEHRING DIAGNOSTICS, INC. N/T RHEUMATOLOGY CONTROL SL/1, SL/2 10/03/1994
K003851 BIOCHECK, INC. BIOCHECK HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1119 07/20/2001
K904312 BIOKIT USA, INC. RHEUMAGEN CRP T-CONTROL 10/01/1990
K871055 BOEHRINGER MANNHEIM CORP. PRECIMAT(R) CRP 05/06/1987
K930621 BOEHRINGER MANNHEIM CORP. TINA-QUANT CRP 03/10/1993
K871895 BOEHRINGER MANNHEIM CORP. TINA-QUANT [A] CRP 06/15/1987
K792238 CENTRAL BIOLOGICAL CO. CRPTELL 11/30/1979
K040579 CHOLESTECH CORP. CHOLETECH LDX HIGH-SENSITIVITY C-REACTIVE PROTEIN (HS-CRP) 06/18/2004
K946050 CLINICAL CONTROLS, INC. LIQUISPEX(TM) LIQUID CRP CONTROL LEVEL 1 AND 2 02/10/1995
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
K914155 CRESTAT DIAGNOSTICS, INC. TIA CRP TEST KIT 01/15/1992
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
K945280 DUPONT MEDICAL PRODUCTS DUPONT DIMENSION C-REACTIVE PROTEIN METHOD 03/09/1995
K863328 E.I. DUPONT DE NEMOURS & CO., INC. ACA(R) C-REACTIVE PROTEIN (CRP) ANALYTICAL TEST 09/26/1986
K863329 E.I. DUPONT DE NEMOURS & CO., INC. ACA(R) C-REACTIVE PROTEIN (CRP) CALIBRATOR 09/26/1986
K860550 E.I. DUPONT DE NEMOURS & CO., INC. DU PONT C-REACTIVE PROTEIN (CRP) ASSAY 06/10/1986
K860549 E.I. DUPONT DE NEMOURS & CO., INC. DU PONT C-REACTIVE PROTEIN (CRP) CALIBRATOR 06/10/1986
K884101 E.I. DUPONT DE NEMOURS & CO., INC. DU PONT DIMENSION C-REACTIVE PROTEIN CALIBRATOR 10/19/1988
K850160 FISHER DIAGNOSTICS FISHER DIAGNOSTICS LATEST-CRP TEST KIT 04/19/1985
K760035 GAMMA BIOLOGICALS, INC. TEST, C-REATIVE PROTEIN, LATEX SLIDE 08/03/1976
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
K944288 HEMAGEN DIAGNOSTICS, INC. HEMAGEN C-REACTIVE PROTEIN KIT (EIA METHOD) 10/03/1994
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
K760354 ICL SCIENTIFIC TEST, SLIDE FOR C-REATIVE PROTEIN 08/11/1976
K894573 IMMUNTECH A/S SCANLISA HUMAN CRP ELISA KIT 08/10/1989
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
K953926 INTERNATIONAL ENZYMES, INC. LINICAL PROTEIN III CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN ARRAY PROTEIN SYSTEM 09/15/1995
K832054 INTL. DIAGNOSTIC TECHNOLOGY FIAX CRP TEST KIT 08/26/1983
K924332 J.S. MEDICAL ASSOC. ACCUTEX CRP LATEX TEST 12/07/1992
K953197 JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. EKTACHEM CLINICAL CHEMISTRY SLIDE C-REACTIVE PROTEIN (CRP) 07/31/1995
K880730 KALLESTAD DIAG, A DIV. OF ERBAMONT, INC. KALLESTAD QM2/QM300 CONTROL C PACK 03/25/1988
K880729 KALLESTAD DIAG, A DIV. OF ERBAMONT, INC. KALLESTAD QM300 CALIBRATOR C PACK 03/30/1988
K821984 KALLESTAD LABORATORIES, INC. QUANTIMETRIC 2 C-REACTIVE PROTEIN REAG. 07/22/1982
K811617 KALLESTAD LABORATORIES, INC. QUANTIMETRIC C-REACTIVE PROTEIN ASSAY R. 06/25/1981
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
K022486 KAMIYA BIOMEDICAL CO. K-ASSAY HS-CRP CONTROLS 08/14/2002
K011079 KAMIYA BIOMEDICAL CO. K-ASSAY HS-CRP CONTROLS 05/16/2001
K831958 KENT LABORATORIES, INC. RADIAL IMMUNO-TEST FOR HUMAN C-REACTI 07/19/1983
K854221 MARVIC INTERPHARMA, INC. DIESSE CRP TEST KIT 11/25/1985
K951057 MEDICAL ANALYSIS SYSTEMS, INC. MAS LIQUID ASSAYED ALCOHOL/AMMONIA CONTROL LEVEL 1 AND 2 04/20/1995
K841862 MEDILAB CORP. IMMU-TEC 06/13/1984
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
K791560 PROTOS LABORATORIES GOAT ANTI-HUMAN C-REACTIVE PROTEIN 09/24/1979
K923768 PULSE SCIENTIFIC, INC. PULSE CRP TEST 12/01/1992
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
K953212 RANDOX LABORATORIES, LTD. C-REACTIVE PROTEIN IMMUNOTURBIDIMETRIC KIT & CRP CALIBRATOR 07/31/1995
K954447 RANDOX LABORATORIES, LTD. C-REACTIVE PROTEIN LATEX KIT 12/18/1995
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
K880016 SCLAVO, INC. MODIFIED CRP LATEX TEST 02/25/1988
K050836 SENTINEL CH. SRL CRP DIAGNOSTIC ASSAY 08/08/2005
K922722 SIMPLICITY DIAGNOSTICS, INC. TECH DIMPLE C-REACTIVE PROTEIN SERUM CONTROL 10/05/1992
K041155 STANBIO LABORATORY WIDE RANGE C-REACTIVE PROTEIN (WR CRP) ASSAY 10/14/2004
K821412 SYVA CO. C-REACTIVE PROTEIN CONTROL 07/22/1982
K822067 SYVA CO. EMIT C-REACTIVE PROTEIN AUTOCAROUSEL 07/27/1982
K823416 SYVA CO. PRISMA C-REACTIVE PROTEIN ASSAY 12/09/1982
K823415 SYVA CO. PRISMA C-REACTIVE PROTEIN CONTROLS 12/09/1982
K823417 SYVA CO. PRISMA-C-REACTIVE PROTEIN CALIBRATORS 12/09/1982
K863628 TECHNICON INSTRUMENTS CORP. C-REACTIVE PROTEIN (CRP), FOR TECHNICON RA SYSTEMS 10/15/1986
K892198 TECHNICON INSTRUMENTS CORP. TECHNICON DPA-1 (TM) CRP METHOD 05/09/1989
K962019 TECO DIAGNOSTICS C-REACTIVE PROTEIN (CRP):A LATEX SLIDE TEST 11/25/1996
K890423 TEXAS IMMUNOLOGY, INC. V-TREND TARGET CRP TEST 02/17/1989
K001636 THE BINDING SITE, LTD. C-REACTIVE PROTEIN ANTISERUM KIT 08/24/2000
K953207 THE BINDING SITE, LTD. HUMAN C-REACTIVE PROTEIN KIT (MODIFICATION) 08/01/1995
K905633 THE BINDING SITE, LTD. HUMAN C-REACTIVE PROTEIN RID KIT 07/22/1991
K972160 TRINITY LABORATORIES, INC. CRP-LEX SYSTEM: C-REACTIVE PROTEIN ANTIGEN DETECTION IN SERUM: SLIDE AGGLUTNATION LATEX TEST 08/01/1997
K873865 UNIPATH LTD. CRP 10/13/1987
K973692 UNITED BIOTECH, INC. UBI MAGIWEL C-REACTIVE PROTEIN(CRP) QUANTITATIVE 02/09/1998
K791461 VOLU SOL MEDICAL INDUSTRIES AGGLUTINOTEST-C-REACTIVE PROTEIN 12/31/1979
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
K895598 WAKO CHEMICALS, USA, INC. WAKO(TM) AUTOKIT CRP 09/27/1989


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