FDA Product Code
FDA Product Code DCN — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5270
510(k) Clearances — 70 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K232624 | CardioPhase® hsCRP | Siemens Healthcare Diagnostic Products GmbH | 2023-11-27 | Traditional | PDF ↗ |
| K221119 | RCRP Flex reagent cartridge | Siemens Healthcare Diagnostics, Inc. | 2023-03-17 | Special | PDF ↗ |
| K192072 | Tina-quant C-Reactive Protein IV | Roche Diagnostics Operations (Rdo) | 2020-02-21 | Traditional | PDF ↗ |
| K180099 | Optilite High Sensitivity C-Reactive Protein Kit | The Binding Site Group , Ltd. | 2018-10-12 | Traditional | PDF ↗ |
| K172868 | Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls | The Binding Site Group , Ltd. | 2018-02-28 | Traditional | PDF ↗ |
| K171498 | MSD CRP Assay Kit and MESO SECTOR S 700 Instrument | Meso Scale Diagnostics, LLC | 2018-01-12 | Traditional | PDF ↗ |
| K161982 | C-Reactive Protein Kit for use on SPAPLUS | The Binding Site Group | 2017-04-05 | Traditional | PDF ↗ |
| K113809 | HITACHI CLINICAL ANALYZER S TEST REGENT CARTRIDGE C-REACTIVE PROTEIN (CRP) | Hitachi Chemical Diagnostics, Inc. | 2012-08-17 | Traditional | PDF ↗ |
| K091052 | PICCOLO C-REACTIVE PROTEIN (CRP) TEST SYSTEM | Abaxis, Inc. | 2010-01-15 | Traditional | PDF ↗ |
| K083444 | C-REACTIVE PROTEIN (LATEX) | Roche Diagnostics Corp. | 2009-03-18 | Traditional | PDF ↗ |
| K083412 | PATHFAST HSCRP | Mitsubishi Kagaku Iatron | 2009-03-09 | Traditional | PDF ↗ |
| K083040 | S-TEST C-REACTIVE PROTEIN (CRP) | Alfa Wassermann Diagnostic Technologies, Inc. | 2009-01-30 | Traditional | PDF ↗ |
| K072658 | ADVIA CHEMISTRY C-REACTIVE PROTEIN_2, (CRP_2) AND CALIBRATORS | Siemens Medical Solutions Diagnostics | 2008-04-01 | Traditional | PDF ↗ |
| K073277 | ROCHE-CREACTIVE PROTEIN (LATEX) | Roche Diagnostics Corp. | 2008-03-06 | Special | PDF ↗ |
| K062981 | I-CHROMA CRP TEST | Boditech Diagnostics, Inc. | 2007-07-13 | Traditional | PDF ↗ |
| K061825 | DIMENSION VISTA CRP FLEX REAGENT CARTRIDGE, PROTEIN 2 CALIBRATOR, CONTROL LOW AND CONTROL HIGH | Dade Behring, Inc. | 2006-09-06 | Traditional | PDF ↗ |
| K050713 | DUET HS-CRP LIT ASSAY, CATALOG NUMBER: 4010, DUET HS-CRP CALIBRATOR SET, CATALOG NUMBER: 4511 | Good Biotech Corp. | 2005-06-06 | Traditional | PDF ↗ |
| K040030 | BIOCHECK CARDIAC-1 CRP RAPID TEST, MODEL BC-804114 | Biocheck, Inc. | 2004-06-16 | Traditional | PDF ↗ |
| K032336 | TINA-QUANT CRP (LATEX) | Roche Diagnostics Corp. | 2003-08-05 | Special | PDF ↗ |
| K030899 | C-REACTIVE PROTEIN (CRP) | Abbott Laboratories | 2003-07-02 | Traditional | PDF ↗ |
| K022690 | PAROS CRP | Horiba, Ltd. | 2002-12-23 | Traditional | PDF ↗ |
| K021757 | CRPEX-BR C-REACTIVE PROTEIN LIT ASSAY, CRPEX-BR CRP CALIBRATOR SET | Good Biotech Corp. | 2002-07-29 | Traditional | PDF ↗ |
| K021572 | SYNCHRON SYSTEMS C-REACTIVE PROTEIN (C-RP) REAGENT; SYNCHRON SYSTEMS CX C-RP CALIBRATOR | Beckman Coulter, Inc. | 2002-07-19 | Traditional | PDF ↗ |
| K021882 | CRPEX-HS CRP CALIBRATOR SET, CATALOG NO: 1510 | Good Biotech Corp. | 2002-07-11 | Traditional | PDF ↗ |
| K020603 | CRPEX-HS C-REACTIVE PROTEIN LIT ASSAY, CATALOG NO. 1010 | Good Biotech Corp. | 2002-06-13 | Traditional | PDF ↗ |
| K011855 | WAMPOLE HS-CRP ELISA | Carter-Wallace, Inc. | 2002-01-08 | Traditional | PDF ↗ |
| K012337 | BAYER ADVIA IMS SYSTEM; C-REACTIVE PROTEIN SYSTEM | Bayer Corp. | 2001-12-06 | Traditional | PDF ↗ |
| K011958 | CRP-LATEX (II) SEIKEN HIGH SENSITIVITY ASSAY KIT | Denka Seiken'S | 2001-12-04 | Traditional | PDF ↗ |
| K003400 | CRP HS TEST SYSTEM | Roche Diagnostics Corp. | 2001-05-10 | Traditional | PDF ↗ |
| K003419 | RCRP FLEX REAGENT CARTRIDGE | Dade Behring, Inc. | 2001-02-14 | Traditional | PDF ↗ |
| K003342 | WAKO CRP-UL, CRP-UL CALIBRATOR SET | Wako Chemicals USA, Inc. | 2001-01-22 | Traditional | PDF ↗ |
| K003372 | IMMULITE HIGH SENSITIVITY CRP, IMMULITE 2000 HIGH SENSITIVITY CRP | Diagnostic Products Corp. | 2000-12-26 | Traditional | PDF ↗ |
| K002918 | OLYMPUS CRP LATEX IMMUNOTURBIDIMETRIC REAGENT | Olympus America, Inc. | 2000-10-25 | Special | PDF ↗ |
| K991372 | CRP | Abbott Laboratories | 1999-06-01 | Traditional | PDF ↗ |
| K990825 | REVISED C-REACTIVE PROTEIN (RCRP) FLEX REAGENT CARTRIDGE | Dade Behring, Inc. | 1999-04-16 | Traditional | PDF ↗ |
| K974429 | RAPET CRP | Stanbio Laboratory | 1998-02-18 | Traditional | PDF ↗ |
| K954537 | OLYMPUS C-REACTIVE PROTEIN IMMUNOTURBIDIMETRIC REAGENT | Olympus America, Inc. | 1996-02-14 | Traditional | PDF ↗ |
| K955042 | CHROMALEX C-REACTIVE PROTEIN LATEX TEST SYSTEM | Shared Systems, Inc. | 1995-12-13 | Traditional | PDF ↗ |
| K935075 | SPQ CRP CONTROL LEVEL II | Incstar Corp. | 1994-01-11 | Traditional | PDF ↗ |
| K932180 | EYE SPOT CRP TEST | J.S. Medical Assoc. | 1993-08-23 | Traditional | PDF ↗ |
| K910535 | SYNCHRON C-REACTIVE PROTEIN REAGENT | Beckman Instruments, Inc. | 1991-04-12 | Traditional | PDF ↗ |
| K910686 | RHEUMAJET CRP | Biokit USA, Inc. | 1991-03-19 | Traditional | PDF ↗ |
| K904497 | CROMATEST RHEUMATOID DIAGNOSTIC/CRP LATEX TEST | Biotrax, Inc. | 1990-11-01 | Traditional | PDF ↗ |
| K903853 | RAPITEX (R) CRP NEW | Behring Diagnostics, Inc. | 1990-08-30 | Traditional | PDF ↗ |
| K902593 | RAICHEM(TM) SPIA(TM) CRP REAGENT | Reagents Applications, Inc. | 1990-06-28 | Traditional | PDF ↗ |
| K896272 | QUANTEX CRP PLUS (LATEX, BUFFER, STANDARD, CONTROL | Biokit USA, Inc. | 1989-11-08 | Traditional | PDF ↗ |
| K892231 | V-TREND TARGET CRP TEST | Texas Immunology, Inc. | 1989-04-21 | Traditional | PDF ↗ |
| K885001 | QM300 PCR ANTIBODY PACK | Kallestad Diag, A Div. of Erbamont, Inc. | 1988-12-20 | Traditional | PDF ↗ |
| K883515 | DU PONT DIMENSION C-REACTIVE PROTEIN METHOD | E.I. Dupont DE Nemours & Co., Inc. | 1988-09-22 | Traditional | PDF ↗ |
| K882374 | WAKO(TM) CRP | Wako Chemicals USA, Inc. | 1988-07-08 | Traditional | PDF ↗ |
| K880728 | KALLESTAD QM300 C-REACTIVE PROTEIN ANTIBODY PACK | Kallestad Diag, A Div. of Erbamont, Inc. | 1988-03-25 | Traditional | PDF ↗ |
| K872539 | EUROGENETICS CRP ELISA | Eurogenetics | 1987-10-20 | Traditional | PDF ↗ |
| K860679 | IMMUNOCHEMICAL ASSAY OF C-REACTIVE PROTEIN | Orion Corp. | 1986-08-04 | Traditional | PDF ↗ |
| K854819 | CPR SLIDE EIKEN | Syn-Kit, Inc. | 1986-02-26 | Traditional | PDF ↗ |
| K855057 | LASER CRP KIT(C-REACTIVE PROTEIN REAGENTS) | Behring Diagnostics, Inc. | 1986-02-26 | Traditional | PDF ↗ |
| K841265 | TAGO DIFFU-GEN C-REACTIVE PROTEIN | Tago, Inc. | 1984-05-22 | Traditional | PDF ↗ |
| K840699 | CRP SLIDE TEST KIT | Difco Laboratories, Inc. | 1984-03-23 | Traditional | PDF ↗ |
| K834584 | NABI CRP-Q.S. TEST | Intl. Diagnostic, Inc. | 1984-02-27 | Traditional | PDF ↗ |
| K834390 | IMMUNO-CRP | Immunostics Co., Inc. | 1984-02-03 | Traditional | PDF ↗ |
| K831465 | CRP-CHECK | Diagnostic Technology, Inc. | 1983-06-08 | Traditional | PDF ↗ |
| K831364 | TESTCORP RA | Myo-Tronics Research, Inc. | 1983-05-27 | Traditional | PDF ↗ |
| K831362 | TESTCORP CRP | Catheter Technology Corp. | 1983-05-27 | Traditional | PDF ↗ |
| K821388 | SERO/TEX CRP TEST | Texas Immunology, Inc. | 1982-07-02 | Traditional | PDF ↗ |
| K821413 | EMIT C-REACTIVE PROTEIN ASSAY | Syva Co. | 1982-05-28 | Traditional | PDF ↗ |
| K812881 | IMMUNEX CRP | Armkel, LLC | 1981-10-26 | Traditional | PDF ↗ |
| K811374 | BI-CRP LATEX TEST | Biologics Intl., Inc. | 1981-06-12 | Traditional | PDF ↗ |
| K810862 | CRP SLIDE | Syn-Kit, Inc. | 1981-04-08 | Traditional | PDF ↗ |
| K790716 | ANTISERUM TO HUMAN C-REACTIVE PROTEINS | Kent Laboratories, Inc. | 1979-08-03 | Traditional | PDF ↗ |
| K771535 | LAS-R HUMAN CRP TEST | Hyland Therapeutic Div., Travenol Laboratories | 1977-09-02 | Traditional | PDF ↗ |
| K771139 | CRP-WELLCOTEST | Burroughs Wellcome Co. | 1977-07-14 | Traditional | PDF ↗ |
Product code DCN · Class II · Immunology. Data: openFDA.