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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