Panels › Immunology › Product code DCK · Class 2
C-Reactive Protein, Antigen, Antiserum, And Control
Regulation 866.5270
0510(k)s in 12 months (126 all time)
0recalls in 12 months (17 all time)
16recalls that name a 510(k)
Top companies in DCK
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 18, 2025 | K242170 | K-ASSAY CRP (Ver.2) Kamiya Biomedical Company, LLC | DCK |
| Nov 4, 2022 | K201256 | Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge Procise Diagnostics | DCK |
| Jun 25, 2020 | K192028 | Yumizen C1200 CRP HORIBA ABX SAS, FR | DCK |
| Nov 8, 2019 | K192118 | CRP Vario SENTINEL CH. SpA, IT | DCK |
| Oct 3, 2019 | K191993 | Yumizen C1200 CRP HORIBA ABX SAS, FR | DCK |
| Jul 14, 2017 | K160712 | VITROS Chemistry Products hsCRP Reagent Ortho Clinical Diagnostics | DCK |
| Mar 10, 2016 | K142993 | QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument Orion Diagnostica, OY, FI | DCK |
| Sep 24, 2015 | K152433 | VITROS Chemistry Products CRP Slides; VITRO Chemistry Products Calibrator Kit 7 Ortho Clinical Diagnostics | DCK |
| Jan 7, 2015 | K141689 | FastPack High Sensitivity C-Reactive Protein Immunoassay, High Sensitivity C-Reactive Protein Calibrator Kit, FastPack H Qualigen, Inc. | DCK |
| Sep 21, 2012 | K121558 | DIAZYME HSCRP POC TEST KIT Diazyme Laboratories | DCK |
| Apr 27, 2011 | K103557 | DIAZYME HS CRP ASSAY KIT / CALIBRATOR SET / CONTROL SET Diazyme Laboratories | DCK |
| Sep 29, 2006 | K061138 | ABX PENTRA 400 : CRP Horiba Abx, FR | DCK |
| Apr 28, 2006 | K060139 | CRP-ADVANCE ASSAY, MODELS 250-20, 250-25 Diagnostic Chemicals , Ltd., CA | DCK |
| Feb 9, 2006 | K052591 | NANOPIA WIDE RANGE C-REACTIVE PROTEIN (CRP) REAGENT KIT Clinical Data, Inc. | DCK |
| Aug 8, 2005 | K050836 | CRP DIAGNOSTIC ASSAY Sentinel Ch. Srl, IT | DCK |
| Oct 14, 2004 | K041155 | WIDE RANGE C-REACTIVE PROTEIN (WR CRP) ASSAY Stanbio Laboratory | DCK |
| Sep 24, 2004 | K042442 | QUICKREAD SYSTEM: QUICKREAD CRP KIT, MODEL 06085; QUICKREAD 101 INSTRUMENT, MODEL 06088; QUICKREAD CRP CONTROL SET, MODE Orion Diagnostica, OY, FI | DCK |
| Jun 25, 2004 | K040241 | N-GENEOUS WIDE RANGE CRP REAGENT AND CALIBRATOR SET Genzyme Corp. | DCK |
| Jun 18, 2004 | K040579 | CHOLETECH LDX HIGH-SENSITIVITY C-REACTIVE PROTEIN (HS-CRP) Cholestech Corp. | DCK |
| Dec 19, 2003 | K032663 | QUANTEX CRP HIGH SENSITIVITY STANDARD MULTIPOINT, QUANTEX CRP HIGH SENSITIVITY CONTROLS VE CONTROLS 1/2 Instrumentation Laboratory CO | DCK |
| Oct 10, 2003 | K031607 | ORION DIAGNOSTICA QUIKREAD CRP KIT AND QUIKREAD CRP CONTROL Orion Diagnostica, Div. Orion Corp., FI | DCK |
| Sep 30, 2003 | K030044 | EXTENDED RANGE HS CRP KIT, CAT NO:9200 Reference Diagnostics, Inc. | DCK |
| Jun 6, 2003 | K024280 | WAKO CRP, CALIBRATOR AND WAKO CRP CALIBRATOR SET Wako Chemicals USA, Inc. | DCK |
| Jun 2, 2003 | K030545 | CRP-LATEX (II)X2 SEIKEN ASSAY KIT Denka Seiken Co., Ltd., JP | DCK |
| Mar 18, 2003 | K030626 | VITROS CHEMISTRY PRODUCTS CRP SLIDE AND CALIBRATOR KIT 7 Ortho-Clinical Diagnostics, Inc. | DCK |
| Feb 4, 2003 | K023828 | K-ASSAY C-REACTIVE PROTEIN (3), K-ASSAY CRP MULTI-CALIBRATOR D, K-ASSAY CRP MULTI-CALIBRATOR E, K-ASSAY CRP MULTI-CALIBR Kamiya Biomedical Co. | DCK |
| Dec 23, 2002 | K023269 | HEMOSIL C-REACTIVE PROTEIN - HIGH SENSITIVITY AND HIGH SENSITIVITY CONTROLS Instrumentation Laboratory CO | DCK |
| Dec 3, 2002 | K022176 | ORION DIAGNOSTICA ULTRASENSITIVE CRP KIT, MODEL 68025, & ORION DIAGNOSTICA ULTRASENSITIVE CRP CONTROL, MODEL 68257 Orion Diagnostica, Div. Orion Corp., FI | DCK |
| Aug 14, 2002 | K022486 | K-ASSAY HS-CRP CONTROLS Kamiya Biomedical Co. | DCK |
| Jul 29, 2002 | K021194 | RAICHEM CRP HIGH SENSITIVITY TEST SYSTEM Hemagen Diagnostics, Inc. | DCK |
| Jun 27, 2002 | K021609 | RDI HS CRP KIT Reference Diagnostics, Inc. | DCK |
| May 14, 2002 | K013787 | NYCOCARD CRP Primus Corp. | DCK |
| Jan 7, 2002 | K014084 | NYCOCARD CRP CONTROL Primus Corp. | DCK |
| Jul 20, 2001 | K003851 | BIOCHECK HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1119 Biocheck, Inc. | DCK |
| May 29, 2001 | K010597 | SYNCHRON LX SYSTEMS HIGH SENSITIVITY C-REACTIVE PROTIEN (CRPH) REAGENT Beckman Coulter, Inc. | DCK |
| May 16, 2001 | K011079 | K-ASSAY HS-CRP CONTROLS Kamiya Biomedical Co. | DCK |
| Apr 5, 2001 | K010236 | IMMAGE IMMUNOCHEMISTRY SYSTEM HIGH SENSITIVITY C-REACTIVE PROTEIN (CRPH) REAGENT Beckman Coulter, Inc. | DCK |
| Oct 25, 2000 | K002558 | K-ASSAY HIGH SENSITIVE CRP(2) FOR THE BECKMAN COULTER IMMAGE Kamiya Biomedical Co. | DCK |
| Oct 13, 2000 | K002651 | C-REACTIVE PROTEIN (HIGH SENSITIVITY) REAGENT SET Pointe Scientific, Inc., | DCK |
| Aug 24, 2000 | K001636 | C-REACTIVE PROTEIN ANTISERUM KIT The Binding Site, Ltd. | DCK |
| Aug 4, 2000 | K001009 | RANDOX C-REACTIVE PROTEIN Randox Laboratories, Ltd., GB | DCK |
| Oct 25, 1999 | K991385 | DADE BEHRING N HIGH SENSITIVITY CRP ASSAY Dade Behring, Inc. | DCK |
| Sep 13, 1999 | K992312 | K-ASSAY CRP (2), K-ASSAY CRP MULTI-CALIBRATOR A, K-ASSAY CRP MULTI-CALIBRATOR B Kamiya Biomedical Co. | DCK |
| Sep 13, 1999 | K992311 | K-ASSAY CRP(1), K-ASSAY CRP MULTI-CALIBRATOR A, K-ASSAY CRP MULTI-CALIBRATORC Kamiya Biomedical Co. | DCK |
| May 14, 1999 | K991224 | K-ASSAY CRP Kamiya Biomedical Co. | DCK |
| May 11, 1999 | K991210 | K-ASSAY CRP CALIBRATOR SET Kamiya Biomedical Co. | DCK |
| May 3, 1999 | K990704 | ARRAY 360 SYSTEM C-REACTIVE PROTEIN (CRP MPE) REAGENT Beckman Coulter, Inc. | DCK |
| Apr 6, 1999 | K990886 | IMMULITE C-REACTIVE PROTEIN, MODEL LKCR1, LKCR5 Diagnostic Products Corp. | DCK |
| Jan 28, 1999 | K984132 | IMMULITE C-REACTIVE PROTEIN, MODELS LKC1, LKC5 Diagnostic Products Corp. | DCK |
| Nov 9, 1998 | K981871 | C-REACTIVE PROTEIN ELISA, MODEL NUMBER DSL-10-42100 Diagnostic Systems Laboratories, Inc. | DCK |
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