FDA Product Code
FDA Product Code DCK — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5270
510(k) Clearances — 126 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K242170 | K-ASSAY CRP (Ver.2) | Kamiya Biomedical Company, LLC | 2025-04-18 | Traditional | PDF ↗ |
| K201256 | Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge | Procise Diagnostics | 2022-11-04 | Traditional | PDF ↗ |
| K192028 | Yumizen C1200 CRP | HORIBA ABX SAS | 2020-06-25 | Traditional | PDF ↗ |
| K192118 | CRP Vario | SENTINEL CH. SpA | 2019-11-08 | Special | PDF ↗ |
| K191993 | Yumizen C1200 CRP | HORIBA ABX SAS | 2019-10-03 | Traditional | PDF ↗ |
| K160712 | VITROS Chemistry Products hsCRP Reagent | Ortho Clinical Diagnostics | 2017-07-14 | Traditional | PDF ↗ |
| K142993 | QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument | Orion Diagnostica, OY | 2016-03-10 | Traditional | PDF ↗ |
| K152433 | VITROS Chemistry Products CRP Slides; VITRO Chemistry Products Calibrator Kit 7 | Ortho Clinical Diagnostics | 2015-09-24 | Special | PDF ↗ |
| K141689 | 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 | Qualigen, Inc. | 2015-01-07 | Traditional | PDF ↗ |
| K121558 | DIAZYME HSCRP POC TEST KIT | Diazyme Laboratories | 2012-09-21 | Traditional | PDF ↗ |
| K103557 | DIAZYME HS CRP ASSAY KIT / CALIBRATOR SET / CONTROL SET | Diazyme Laboratories | 2011-04-27 | Traditional | PDF ↗ |
| K061138 | ABX PENTRA 400 : CRP | Horiba Abx | 2006-09-29 | Traditional | PDF ↗ |
| K060139 | CRP-ADVANCE ASSAY, MODELS 250-20, 250-25 | Diagnostic Chemicals , Ltd. | 2006-04-28 | Traditional | PDF ↗ |
| K052591 | NANOPIA WIDE RANGE C-REACTIVE PROTEIN (CRP) REAGENT KIT | Clinical Data, Inc. | 2006-02-09 | Traditional | PDF ↗ |
| K050836 | CRP DIAGNOSTIC ASSAY | Sentinel Ch. Srl | 2005-08-08 | Traditional | PDF ↗ |
| K041155 | WIDE RANGE C-REACTIVE PROTEIN (WR CRP) ASSAY | Stanbio Laboratory | 2004-10-14 | Traditional | PDF ↗ |
| K042442 | QUICKREAD SYSTEM: QUICKREAD CRP KIT, MODEL 06085; QUICKREAD 101 INSTRUMENT, MODEL 06088; QUICKREAD CRP CONTROL SET, MODE | Orion Diagnostica, OY | 2004-09-24 | Special | PDF ↗ |
| K040241 | N-GENEOUS WIDE RANGE CRP REAGENT AND CALIBRATOR SET | Genzyme Corp. | 2004-06-25 | Traditional | PDF ↗ |
| K040579 | CHOLETECH LDX HIGH-SENSITIVITY C-REACTIVE PROTEIN (HS-CRP) | Cholestech Corp. | 2004-06-18 | Traditional | PDF ↗ |
| K032663 | QUANTEX CRP HIGH SENSITIVITY STANDARD MULTIPOINT, QUANTEX CRP HIGH SENSITIVITY CONTROLS VE CONTROLS 1/2 | Instrumentation Laboratory CO | 2003-12-19 | Traditional | PDF ↗ |
| K031607 | ORION DIAGNOSTICA QUIKREAD CRP KIT AND QUIKREAD CRP CONTROL | Orion Diagnostica, Div. Orion Corp. | 2003-10-10 | Traditional | PDF ↗ |
| K030044 | EXTENDED RANGE HS CRP KIT, CAT NO:9200 | Reference Diagnostics, Inc. | 2003-09-30 | Traditional | PDF ↗ |
| K024280 | WAKO CRP, CALIBRATOR AND WAKO CRP CALIBRATOR SET | Wako Chemicals USA, Inc. | 2003-06-06 | Traditional | PDF ↗ |
| K030545 | CRP-LATEX (II)X2 SEIKEN ASSAY KIT | Denka Seiken Co., Ltd. | 2003-06-02 | Traditional | PDF ↗ |
| K030626 | VITROS CHEMISTRY PRODUCTS CRP SLIDE AND CALIBRATOR KIT 7 | Ortho-Clinical Diagnostics, Inc. | 2003-03-18 | Special | PDF ↗ |
| 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. | 2003-02-04 | Traditional | PDF ↗ |
| K023269 | HEMOSIL C-REACTIVE PROTEIN - HIGH SENSITIVITY AND HIGH SENSITIVITY CONTROLS | Instrumentation Laboratory CO | 2002-12-23 | Traditional | PDF ↗ |
| K022176 | ORION DIAGNOSTICA ULTRASENSITIVE CRP KIT, MODEL 68025, & ORION DIAGNOSTICA ULTRASENSITIVE CRP CONTROL, MODEL 68257 | Orion Diagnostica, Div. Orion Corp. | 2002-12-03 | Traditional | PDF ↗ |
| K022486 | K-ASSAY HS-CRP CONTROLS | Kamiya Biomedical Co. | 2002-08-14 | Traditional | PDF ↗ |
| K021194 | RAICHEM CRP HIGH SENSITIVITY TEST SYSTEM | Hemagen Diagnostics, Inc. | 2002-07-29 | Traditional | PDF ↗ |
| K021609 | RDI HS CRP KIT | Reference Diagnostics, Inc. | 2002-06-27 | Traditional | PDF ↗ |
| K013787 | NYCOCARD CRP | Primus Corp. | 2002-05-14 | Traditional | PDF ↗ |
| K014084 | NYCOCARD CRP CONTROL | Primus Corp. | 2002-01-07 | Traditional | PDF ↗ |
| K003851 | BIOCHECK HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1119 | Biocheck, Inc. | 2001-07-20 | Traditional | PDF ↗ |
| K010597 | SYNCHRON LX SYSTEMS HIGH SENSITIVITY C-REACTIVE PROTIEN (CRPH) REAGENT | Beckman Coulter, Inc. | 2001-05-29 | Traditional | PDF ↗ |
| K011079 | K-ASSAY HS-CRP CONTROLS | Kamiya Biomedical Co. | 2001-05-16 | Traditional | PDF ↗ |
| K010236 | IMMAGE IMMUNOCHEMISTRY SYSTEM HIGH SENSITIVITY C-REACTIVE PROTEIN (CRPH) REAGENT | Beckman Coulter, Inc. | 2001-04-05 | Traditional | PDF ↗ |
| K002558 | K-ASSAY HIGH SENSITIVE CRP(2) FOR THE BECKMAN COULTER IMMAGE | Kamiya Biomedical Co. | 2000-10-25 | Special | PDF ↗ |
| K002651 | C-REACTIVE PROTEIN (HIGH SENSITIVITY) REAGENT SET | Pointe Scientific, Inc., | 2000-10-13 | Traditional | PDF ↗ |
| K001636 | C-REACTIVE PROTEIN ANTISERUM KIT | The Binding Site, Ltd. | 2000-08-24 | Traditional | PDF ↗ |
| K001009 | RANDOX C-REACTIVE PROTEIN | Randox Laboratories, Ltd. | 2000-08-04 | Traditional | PDF ↗ |
| K991385 | DADE BEHRING N HIGH SENSITIVITY CRP ASSAY | Dade Behring, Inc. | 1999-10-25 | Traditional | PDF ↗ |
| K992312 | K-ASSAY CRP (2), K-ASSAY CRP MULTI-CALIBRATOR A, K-ASSAY CRP MULTI-CALIBRATOR B | Kamiya Biomedical Co. | 1999-09-13 | Traditional | PDF ↗ |
| K992311 | K-ASSAY CRP(1), K-ASSAY CRP MULTI-CALIBRATOR A, K-ASSAY CRP MULTI-CALIBRATORC | Kamiya Biomedical Co. | 1999-09-13 | Traditional | PDF ↗ |
| K991224 | K-ASSAY CRP | Kamiya Biomedical Co. | 1999-05-14 | Traditional | PDF ↗ |
| K991210 | K-ASSAY CRP CALIBRATOR SET | Kamiya Biomedical Co. | 1999-05-11 | Traditional | PDF ↗ |
| K990704 | ARRAY 360 SYSTEM C-REACTIVE PROTEIN (CRP MPE) REAGENT | Beckman Coulter, Inc. | 1999-05-03 | Traditional | PDF ↗ |
| K990886 | IMMULITE C-REACTIVE PROTEIN, MODEL LKCR1, LKCR5 | Diagnostic Products Corp. | 1999-04-06 | Special | PDF ↗ |
| K984132 | IMMULITE C-REACTIVE PROTEIN, MODELS LKC1, LKC5 | Diagnostic Products Corp. | 1999-01-28 | Traditional | PDF ↗ |
| K981871 | C-REACTIVE PROTEIN ELISA, MODEL NUMBER DSL-10-42100 | Diagnostic Systems Laboratories, Inc. | 1998-11-09 | Traditional | PDF ↗ |
| K982087 | ROCHE CRP T CONTROL N | Roche Diagnostic Systems, Inc. | 1998-08-18 | Traditional | PDF ↗ |
| K981638 | IMMAGE IMMUNOCHEMISTRY SYSTEM C-REACTIVE PROTEIN (CRP) REAGENT | Beckman Coulter, Inc. | 1998-06-12 | Traditional | PDF ↗ |
| K973692 | UBI MAGIWEL C-REACTIVE PROTEIN(CRP) QUANTITATIVE | United Biotech, Inc. | 1998-02-09 | Traditional | PDF ↗ |
| K974050 | SYNCHRON SYSTEMS C-REACTIVE PROTEIN (CRP) REAGENT | Beckman Instruments, Inc. | 1997-11-24 | Traditional | PDF ↗ |
| K972160 | CRP-LEX SYSTEM: C-REACTIVE PROTEIN ANTIGEN DETECTION IN SERUM: SLIDE AGGLUTNATION LATEX TEST | Trinity Laboratories, Inc. | 1997-08-01 | Traditional | PDF ↗ |
| K965110 | N-ASSAY TIA MULTI CRP CALIBRATOR SET | Crestat Diagnostics, Inc. | 1997-07-03 | Traditional | PDF ↗ |
| K962049 | C-REACTIVE PROTEIN (CRP) AGGLUTINATION LATEX KIT | Polymedco, Inc. | 1996-12-18 | Traditional | PDF ↗ |
| K962019 | C-REACTIVE PROTEIN (CRP):A LATEX SLIDE TEST | Teco Diagnostics | 1996-11-25 | Traditional | PDF ↗ |
| K963061 | IMMAGE IMMUNOCHEMISTRY SYSTEM C-REACTIVE PROTEIN (CRP) REAGENT | Beckman Instruments, Inc. | 1996-11-04 | Traditional | PDF ↗ |
| K961829 | QUALITROL CRP CONTROL SET | Consolidated Technologies, Inc. | 1996-08-19 | Traditional | PDF ↗ |
| K962373 | N/T RHEUMATOLOGY CONTROL SL/1 AND SL/2 | Behring Diagnostics, Inc. | 1996-07-11 | Traditional | PDF ↗ |
| K962523 | N LATEX CRP MONO REAGENT | Behring Diagnostics, Inc. | 1996-07-10 | Traditional | PDF ↗ |
| K960702 | CRP-LATEX SEIKEN XR REAGENT SYSTEM | Globe Management Support, Inc. | 1996-04-19 | Traditional | PDF ↗ |
| K960324 | HEMAGEN CRP 150 KIT (EIA METHOD) | Hemagen Diagnostics, Inc. | 1996-03-12 | Traditional | PDF ↗ |
| K955156 | WAKO AUTOKIT CRP NEW | Wako Chemicals USA, Inc. | 1996-02-16 | Traditional | PDF ↗ |
| K954447 | C-REACTIVE PROTEIN LATEX KIT | Randox Laboratories, Ltd. | 1995-12-18 | Traditional | PDF ↗ |
| K953926 | LINICAL PROTEIN III CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN ARRAY PROTEIN SYSTEM | International Enzymes, Inc. | 1995-09-15 | Traditional | PDF ↗ |
| K953207 | HUMAN C-REACTIVE PROTEIN KIT (MODIFICATION) | The Binding Site, Ltd. | 1995-08-01 | Traditional | PDF ↗ |
| K953197 | EKTACHEM CLINICAL CHEMISTRY SLIDE C-REACTIVE PROTEIN (CRP) | Johnson & Johnson Clinical Diagnostics, Inc. | 1995-07-31 | Traditional | PDF ↗ |
| K953212 | C-REACTIVE PROTEIN IMMUNOTURBIDIMETRIC KIT & CRP CALIBRATOR | Randox Laboratories, Ltd. | 1995-07-31 | Traditional | PDF ↗ |
| K951057 | MAS LIQUID ASSAYED ALCOHOL/AMMONIA CONTROL LEVEL 1 AND 2 | Medical Analysis Systems, Inc. | 1995-04-20 | Traditional | PDF ↗ |
| K945280 | DUPONT DIMENSION C-REACTIVE PROTEIN METHOD | Dupont Medical Products | 1995-03-09 | Traditional | PDF ↗ |
| K946050 | LIQUISPEX(TM) LIQUID CRP CONTROL LEVEL 1 AND 2 | Clinical Controls, Inc. | 1995-02-10 | Traditional | PDF ↗ |
| K944375 | N/T RHEUMATOLOGY CONTROL SL/1, SL/2 | Behring Diagnostics, Inc. | 1994-10-03 | Traditional | PDF ↗ |
| K944288 | HEMAGEN C-REACTIVE PROTEIN KIT (EIA METHOD) | Hemagen Diagnostics, Inc. | 1994-10-03 | Traditional | PDF ↗ |
| K930621 | TINA-QUANT CRP | Boehringer Mannheim Corp. | 1993-03-10 | Traditional | PDF ↗ |
| K920845 | VIGIL II | Beckman Instruments, Inc. | 1992-12-07 | Traditional | PDF ↗ |
| K924332 | ACCUTEX CRP LATEX TEST | J.S. Medical Assoc. | 1992-12-07 | Traditional | PDF ↗ |
| K923768 | PULSE CRP TEST | Pulse Scientific, Inc. | 1992-12-01 | Traditional | PDF ↗ |
| K922722 | TECH DIMPLE C-REACTIVE PROTEIN SERUM CONTROL | Simplicity Diagnostics, Inc. | 1992-10-05 | Traditional | PDF ↗ |
| K914155 | TIA CRP TEST KIT | Crestat Diagnostics, Inc. | 1992-01-15 | Traditional | PDF ↗ |
| K905633 | HUMAN C-REACTIVE PROTEIN RID KIT | The Binding Site, Ltd. | 1991-07-22 | Traditional | PDF ↗ |
| K904312 | RHEUMAGEN CRP T-CONTROL | Biokit USA, Inc. | 1990-10-01 | Traditional | PDF ↗ |
| K895598 | WAKO(TM) AUTOKIT CRP | Wako Chemicals USA, Inc. | 1989-09-27 | Traditional | PDF ↗ |
| K894573 | SCANLISA HUMAN CRP ELISA KIT | Immuntech A/S | 1989-08-10 | Traditional | PDF ↗ |
| K892198 | TECHNICON DPA-1 (TM) CRP METHOD | Technicon Instruments Corp. | 1989-05-09 | Traditional | PDF ↗ |
| K892526 | SPQ TM TEST SYSTEM II FOR CRP | Atlantic Antibodies | 1989-05-09 | Traditional | PDF ↗ |
| K892146 | C REACTIVE PROTEIN LIQUID | Ampcor, Inc. | 1989-04-14 | Traditional | PDF ↗ |
| K892119 | QUIK-DOT C REACTIVE PROTEIN | Ampcor, Inc. | 1989-04-14 | Traditional | PDF ↗ |
| K890423 | V-TREND TARGET CRP TEST | Texas Immunology, Inc. | 1989-02-17 | Traditional | PDF ↗ |
| K884101 | DU PONT DIMENSION C-REACTIVE PROTEIN CALIBRATOR | E.I. Dupont DE Nemours & Co., Inc. | 1988-10-19 | Traditional | PDF ↗ |
| K882998 | ACUTE PHASE C-REACTIVE PROTEIN LATEX AGGLU. TEST | Amtec Diagnostics International, Inc. | 1988-09-07 | Traditional | PDF ↗ |
| K880729 | KALLESTAD QM300 CALIBRATOR C PACK | Kallestad Diag, A Div. of Erbamont, Inc. | 1988-03-30 | Traditional | PDF ↗ |
| K880730 | KALLESTAD QM2/QM300 CONTROL C PACK | Kallestad Diag, A Div. of Erbamont, Inc. | 1988-03-25 | Traditional | PDF ↗ |
| K875345 | VISION(R) CRP | Abbott Laboratories | 1988-03-21 | Traditional | PDF ↗ |
| K880016 | MODIFIED CRP LATEX TEST | Sclavo, Inc. | 1988-02-25 | Traditional | PDF ↗ |
| K873865 | CRP | Unipath , Ltd. | 1987-10-13 | Traditional | PDF ↗ |
| K871895 | TINA-QUANT [A] CRP | Boehringer Mannheim Corp. | 1987-06-15 | Traditional | PDF ↗ |
| K871055 | PRECIMAT(R) CRP | Boehringer Mannheim Corp. | 1987-05-06 | Traditional | PDF ↗ |
| K864131 | VISION(TM) CRP | Abbott Laboratories | 1987-03-16 | Traditional | PDF ↗ |
Product code DCK · Class II · Immunology. Data: openFDA.