FDA 510(k) Applications for Medical Device Product Code "DCN"
(System, Test, C-Reactive Protein)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| 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 |
| 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 |
| K040030 | BIOCHECK, INC. | BIOCHECK CARDIAC-1 CRP RAPID TEST, MODEL BC-804114 | 06/16/2004 |
| K062981 | BODITECH DIAGNOSTICS, INC. | I-CHROMA CRP TEST | 07/13/2007 |
| 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 |
| 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 |
| 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 |
| 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 |
| K192072 | Roche Diagnostics Operations (RDO) | Tina-quant C-Reactive Protein IV | 02/21/2020 |
| K221119 | Siemens Healthcare Diagnostics Inc. | RCRP Flex reagent cartridge | 03/17/2023 |
| 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 |
| K161982 | THE BINDING SITE GROUP | C-Reactive Protein Kit for use on SPAPLUS | 04/05/2017 |
| K180099 | The Binding Site Group Ltd | Optilite High Sensitivity C-Reactive Protein Kit | 10/12/2018 |
| 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 |
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