FDA 510(k) Applications for Medical Device Product Code "DCN"
(System, Test, C-Reactive Protein)

FDA 510(k) Number Applicant Device Name Decision Date
K831362 TESTCORP CRP 05/27/1983
K831364 TESTCORP RA 05/27/1983
K091052 ABAXIS, INC. PICCOLO C-REACTIVE PROTEIN (CRP) TEST SYSTEM 01/15/2010
K030899 ABBOTT LABORATORIES C-REACTIVE PROTEIN (CRP) 07/02/2003
K991372 ABBOTT LABORATORIES CRP 06/01/1999
K083040 ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. S-TEST C-REACTIVE PROTEIN (CRP) 01/30/2009
K812881 ARMKEL, LLC. IMMUNEX CRP 10/26/1981
K012337 BAYER CORP. BAYER ADVIA IMS SYSTEM; C-REACTIVE PROTEIN SYSTEM 12/06/2001
K021572 BECKMAN COULTER, INC. SYNCHRON SYSTEMS C-REACTIVE PROTEIN (C-RP) REAGENT; SYNCHRON SYSTEMS CX C-RP CALIBRATOR 07/19/2002
K910535 BECKMAN INSTRUMENTS, INC. SYNCHRON C-REACTIVE PROTEIN REAGENT 04/12/1991
K855057 BEHRING DIAGNOSTICS, INC. LASER CRP KIT(C-REACTIVE PROTEIN REAGENTS) 02/26/1986
K903853 BEHRING DIAGNOSTICS, INC. RAPITEX (R) CRP NEW 08/30/1990
K040030 BIOCHECK, INC. BIOCHECK CARDIAC-1 CRP RAPID TEST, MODEL BC-804114 06/16/2004
K896272 BIOKIT USA, INC. QUANTEX CRP PLUS (LATEX, BUFFER, STANDARD, CONTROL 11/08/1989
K910686 BIOKIT USA, INC. RHEUMAJET CRP 03/19/1991
K811374 BIOLOGICS INTL., INC. BI-CRP LATEX TEST 06/12/1981
K904497 BIOTRAX, INC. CROMATEST RHEUMATOID DIAGNOSTIC/CRP LATEX TEST 11/01/1990
K062981 BODITECH DIAGNOSTICS, INC. I-CHROMA CRP TEST 07/13/2007
K771139 BURROUGHS WELLCOME CO. CRP-WELLCOTEST 07/14/1977
K011855 CARTER-WALLACE, INC. WAMPOLE HS-CRP ELISA 01/08/2002
K061825 DADE BEHRING, INC. DIMENSION VISTA CRP FLEX REAGENT CARTRIDGE, PROTEIN 2 CALIBRATOR, CONTROL LOW AND CONTROL HIGH 09/06/2006
K003419 DADE BEHRING, INC. RCRP FLEX REAGENT CARTRIDGE 02/14/2001
K990825 DADE BEHRING, INC. REVISED C-REACTIVE PROTEIN (RCRP) FLEX REAGENT CARTRIDGE 04/16/1999
K011958 DENKA SEIKEN'S CRP-LATEX (II) SEIKEN HIGH SENSITIVITY ASSAY KIT 12/04/2001
K003372 DIAGNOSTIC PRODUCTS CORP. IMMULITE HIGH SENSITIVITY CRP, IMMULITE 2000 HIGH SENSITIVITY CRP 12/26/2000
K831465 DIAGNOSTIC TECHNOLOGY, INC. CRP-CHECK 06/08/1983
K840699 DIFCO LABORATORIES, INC. CRP SLIDE TEST KIT 03/23/1984
K883515 E.I. DUPONT DE NEMOURS & CO., INC. DU PONT DIMENSION C-REACTIVE PROTEIN METHOD 09/22/1988
K872539 EUROGENETICS EUROGENETICS CRP ELISA 10/20/1987
K021757 GOOD BIOTECH CORP. CRPEX-BR C-REACTIVE PROTEIN LIT ASSAY, CRPEX-BR CRP CALIBRATOR SET 07/29/2002
K020603 GOOD BIOTECH CORP. CRPEX-HS C-REACTIVE PROTEIN LIT ASSAY, CATALOG NO. 1010 06/13/2002
K021882 GOOD BIOTECH CORP. CRPEX-HS CRP CALIBRATOR SET, CATALOG NO: 1510 07/11/2002
K050713 GOOD BIOTECH CORP. DUET HS-CRP LIT ASSAY, CATALOG NUMBER: 4010, DUET HS-CRP CALIBRATOR SET, CATALOG NUMBER: 4511 06/06/2005
K113809 HITACHI CHEMICAL DIAGNOSTICS, INC. HITACHI CLINICAL ANALYZER S TEST REGENT CARTRIDGE C-REACTIVE PROTEIN (CRP) 08/17/2012
K022690 HORIBA LTD. PAROS CRP 12/23/2002
K771535 HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES LAS-R HUMAN CRP TEST 09/02/1977
K834390 IMMUNOSTICS CO., INC. IMMUNO-CRP 02/03/1984
K935075 INCSTAR CORP. SPQ CRP CONTROL LEVEL II 01/11/1994
K834584 INTL. DIAGNOSTIC, INC. NABI CRP-Q.S. TEST 02/27/1984
K932180 J.S. MEDICAL ASSOC. EYE SPOT CRP TEST 08/23/1993
K880728 KALLESTAD DIAG, A DIV. OF ERBAMONT, INC. KALLESTAD QM300 C-REACTIVE PROTEIN ANTIBODY PACK 03/25/1988
K885001 KALLESTAD DIAG, A DIV. OF ERBAMONT, INC. QM300 PCR ANTIBODY PACK 12/20/1988
K790716 KENT LABORATORIES, INC. ANTISERUM TO HUMAN C-REACTIVE PROTEINS 08/03/1979
K171498 Meso Scale Diagnostics, LLC MSD CRP Assay Kit and MESO SECTOR S 700 Instrument 01/12/2018
K083412 MITSUBISHI KAGAKU IATRON PATHFAST HSCRP 03/09/2009
K954537 OLYMPUS AMERICA, INC. OLYMPUS C-REACTIVE PROTEIN IMMUNOTURBIDIMETRIC REAGENT 02/14/1996
K002918 OLYMPUS AMERICA, INC. OLYMPUS CRP LATEX IMMUNOTURBIDIMETRIC REAGENT 10/25/2000
K860679 ORION CORP. IMMUNOCHEMICAL ASSAY OF C-REACTIVE PROTEIN 08/04/1986
K902593 REAGENTS APPLICATIONS, INC. RAICHEM(TM) SPIA(TM) CRP REAGENT 06/28/1990
K083444 ROCHE DIAGNOSTICS CORP. C-REACTIVE PROTEIN (LATEX) 03/18/2009
K003400 ROCHE DIAGNOSTICS CORP. CRP HS TEST SYSTEM 05/10/2001
K073277 ROCHE DIAGNOSTICS CORP. ROCHE-CREACTIVE PROTEIN (LATEX) 03/06/2008
K032336 ROCHE DIAGNOSTICS CORP. TINA-QUANT CRP (LATEX) 08/05/2003
K955042 SHARED SYSTEMS, INC. CHROMALEX C-REACTIVE PROTEIN LATEX TEST SYSTEM 12/13/1995
K072658 SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS ADVIA CHEMISTRY C-REACTIVE PROTEIN_2, (CRP_2) AND CALIBRATORS 04/01/2008
K974429 STANBIO LABORATORY RAPET CRP 02/18/1998
K854819 SYN-KIT, INC. CPR SLIDE "EIKEN" 02/26/1986
K810862 SYN-KIT, INC. CRP SLIDE 04/08/1981
K821413 SYVA CO. EMIT C-REACTIVE PROTEIN ASSAY 05/28/1982
K841265 TAGO, INC. TAGO DIFFU-GEN C-REACTIVE PROTEIN 05/22/1984
K821388 TEXAS IMMUNOLOGY, INC. SERO/TEX CRP TEST 07/02/1982
K892231 TEXAS IMMUNOLOGY, INC. V-TREND TARGET CRP TEST 04/21/1989
K161982 THE BINDING SITE GROUP C-Reactive Protein Kit for use on SPAPLUS 04/05/2017
K172868 The Binding Site Group Ltd. Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls 02/28/2018
K003342 WAKO CHEMICALS, USA, INC. WAKO CRP-UL, CRP-UL CALIBRATOR SET 01/22/2001
K882374 WAKO CHEMICALS, USA, INC. WAKO(TM) CRP 07/08/1988


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