Product code DCN
- Device name
- System, Test, C-Reactive Protein
- Medical specialty
- Immunology
- Device class
- 2
- Regulation number
- 866.5270
- Review panel
- IM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K232624 | CardioPhase® hsCRP | Siemens Healthcare Diagnostic Products GmbH | 2023-11-27 |
| K221119 | RCRP Flex reagent cartridge | Siemens Healthcare Diagnostics, Inc. | 2023-03-17 |
| K192072 | Tina-quant C-Reactive Protein IV | Roche Diagnostics Operations (Rdo) | 2020-02-21 |
| K180099 | Optilite High Sensitivity C-Reactive Protein Kit | The Binding Site Group , Ltd. | 2018-10-12 |
| K172868 | Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls | The Binding Site Group , Ltd. | 2018-02-28 |
| K171498 | MSD CRP Assay Kit and MESO SECTOR S 700 Instrument | Meso Scale Diagnostics, LLC | 2018-01-12 |
| K161982 | C-Reactive Protein Kit for use on SPAPLUS | The Binding Site Group | 2017-04-05 |
| K113809 | HITACHI CLINICAL ANALYZER S TEST REGENT CARTRIDGE C-REACTIVE PROTEIN (CRP) | Hitachi Chemical Diagnostics, Inc. | 2012-08-17 |
| K091052 | PICCOLO C-REACTIVE PROTEIN (CRP) TEST SYSTEM | Abaxis, Inc. | 2010-01-15 |
| K083444 | C-REACTIVE PROTEIN (LATEX) | Roche Diagnostics Corp. | 2009-03-18 |
| K083412 | PATHFAST HSCRP | Mitsubishi Kagaku Iatron | 2009-03-09 |
| K083040 | S-TEST C-REACTIVE PROTEIN (CRP) | Alfa Wassermann Diagnostic Technologies, Inc. | 2009-01-30 |
| K072658 | ADVIA CHEMISTRY C-REACTIVE PROTEIN_2, (CRP_2) AND CALIBRATORS | Siemens Medical Solutions Diagnostics | 2008-04-01 |
| K073277 | ROCHE-CREACTIVE PROTEIN (LATEX) | Roche Diagnostics Corp. | 2008-03-06 |
| K062981 | I-CHROMA CRP TEST | Boditech Diagnostics, Inc. | 2007-07-13 |
| K061825 | DIMENSION VISTA CRP FLEX REAGENT CARTRIDGE, PROTEIN 2 CALIBRATOR, CONTROL LOW AND CONTROL HIGH | Dade Behring, Inc. | 2006-09-06 |
| K050713 | DUET HS-CRP LIT ASSAY, CATALOG NUMBER: 4010, DUET HS-CRP CALIBRATOR SET, CATALOG NUMBER: 4511 | Good Biotech Corp. | 2005-06-06 |
| K040030 | BIOCHECK CARDIAC-1 CRP RAPID TEST, MODEL BC-804114 | Biocheck, Inc. | 2004-06-16 |
| K032336 | TINA-QUANT CRP (LATEX) | Roche Diagnostics Corp. | 2003-08-05 |
| K030899 | C-REACTIVE PROTEIN (CRP) | Abbott Laboratories | 2003-07-02 |
| K022690 | PAROS CRP | Horiba, Ltd. | 2002-12-23 |
| K021757 | CRPEX-BR C-REACTIVE PROTEIN LIT ASSAY, CRPEX-BR CRP CALIBRATOR SET | Good Biotech Corp. | 2002-07-29 |
| K021572 | SYNCHRON SYSTEMS C-REACTIVE PROTEIN (C-RP) REAGENT; SYNCHRON SYSTEMS CX C-RP CALIBRATOR | Beckman Coulter, Inc. | 2002-07-19 |
| K021882 | CRPEX-HS CRP CALIBRATOR SET, CATALOG NO: 1510 | Good Biotech Corp. | 2002-07-11 |
| K020603 | CRPEX-HS C-REACTIVE PROTEIN LIT ASSAY, CATALOG NO. 1010 | Good Biotech Corp. | 2002-06-13 |
| K011855 | WAMPOLE HS-CRP ELISA | Carter-Wallace, Inc. | 2002-01-08 |
| K012337 | BAYER ADVIA IMS SYSTEM; C-REACTIVE PROTEIN SYSTEM | Bayer Corp. | 2001-12-06 |
| K011958 | CRP-LATEX (II) SEIKEN HIGH SENSITIVITY ASSAY KIT | Denka Seiken'S | 2001-12-04 |
| K003400 | CRP HS TEST SYSTEM | Roche Diagnostics Corp. | 2001-05-10 |
| K003419 | RCRP FLEX REAGENT CARTRIDGE | Dade Behring, Inc. | 2001-02-14 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00630414610887 | Atellica CH Revised C-Reactive Protein (RCRP) | Siemens Healthcare Diagnostics Inc. | 2024-02-02 |
| 00630414305127 | Atellica CH Revised C-Reactive Protein (RCRP) | Siemens Healthcare Diagnostics Inc. | 2024-02-02 |
| 00895160002694 | Nano-Check TM CRP plus Test | NANO-DITECH CORPORATION | 2022-03-15 |
| 10895160002691 | Nano-Check TM CRP plus Test | NANO-DITECH CORPORATION | 2022-03-15 |
| 00894175000312 | AccuDiag™ | Diagnostic Automation, Inc. | 2021-08-26 |
| 00895160002670 | Fluoro-CheckTM CRP Test | NANO-DITECH CORPORATION | 2020-09-22 |
| 10895160002677 | Fluoro-CheckTM CRP Test | NANO-DITECH CORPORATION | 2020-09-22 |
| 07613336121191 | Tina-quant C-Reactive Protein IV | Roche Diagnostics GmbH | 2020-06-16 |
| 04015630946839 | Tina-quant CReactive Protein IV | Roche Diagnostics GmbH | 2020-05-13 |
| 00006136471288 | Sure-Vue | FISHER SCIENTIFIC COMPANY L.L.C. | 2017-10-27 |
| 00006136471271 | Sure-Vue | FISHER SCIENTIFIC COMPANY L.L.C. | 2017-10-27 |
| 08806133010099 | ichroma Reader | Boditech Med Inc. | 2017-10-26 |
| 08806679001520 | ichroma™ CRP | Boditech Med Inc. | 2016-12-20 |
| 10859035006016 | IMMUNEX CRP® | ALERE NORTH AMERICA, LLC | 2016-09-24 |
| EABA40000351 | Piccolo BioChemistry Panel Plus | ABAXIS, INC. | 2016-09-23 |
| EABA40000411 | Piccolo AmLyte 13 | ABAXIS, INC. | 2016-09-23 |
| 08426950589365 | Rheumajet CRP 100 TESTS | BIOKIT, S.A. | 2016-09-23 |
| 04015630926916 | Cardiac CReactive Protein Latex High Sensitive | Roche Diagnostics GmbH | 2016-09-20 |
| 10722355001163 | Detector C-Reactacol | Immunostics Company, Inc | 2016-09-20 |
| 04015630927029 | Creactive protein latex) | Roche Diagnostics GmbH | 2016-09-20 |
| 10722355001194 | Detector Lex-CRP | Immunostics Company, Inc | 2016-09-20 |
| 04015630925285 | CReactive Protein Gen3 | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630923939 | CReactive Protein Gen3 | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630923274 | Tinaquant CReactive Protein Gen3 | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630923267 | Tinaquant CReactive Protein Gen3 | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630913633 | CReactive Protein Latex) | Roche Diagnostics GmbH | 2016-09-20 |
| 10722355001170 | Detector C-Reactacol | Immunostics Company, Inc | 2016-09-20 |
| 10722355001187 | Detector Lex-CRP | Immunostics Company, Inc | 2016-09-20 |
| 00895160002052 | Nano-CheckTM hs-CRP | NANO-DITECH CORPORATION | 2016-09-14 |
| 00895160002045 | Nano-CheckTM CRP | NANO-DITECH CORPORATION | 2016-09-14 |