DCN — System, Test, C-Reactive Protein Class II
FDA Device Classification
Classification Details
- Product Code
- DCN
- Device Class
- Class II
- Regulation Number
- 866.5270
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K232624 | siemens healthcare diagnostic products | CardioPhase® hsCRP | November 27, 2023 |
| K221119 | siemens healthcare diagnostics | RCRP Flex reagent cartridge | March 17, 2023 |
| K192072 | roche diagnostics operations (rdo) | Tina-quant C-Reactive Protein IV | February 21, 2020 |
| K180099 | binding site group | Optilite High Sensitivity C-Reactive Protein Kit | October 12, 2018 |
| K172868 | binding site group | Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optil | February 28, 2018 |
| K171498 | meso scale diagnostics | MSD CRP Assay Kit and MESO SECTOR S 700 Instrument | January 12, 2018 |
| K161982 | binding site group | C-Reactive Protein Kit for use on SPAPLUS | April 5, 2017 |
| K113809 | hitachi chemical diagnostics | HITACHI CLINICAL ANALYZER S TEST REGENT CARTRIDGE C-REACTIVE PROTEIN (CRP) | August 17, 2012 |
| K091052 | abaxis | PICCOLO C-REACTIVE PROTEIN (CRP) TEST SYSTEM | January 15, 2010 |
| K083444 | roche diagnostics | C-REACTIVE PROTEIN (LATEX) | March 18, 2009 |
| K083412 | mitsubishi kagaku iatron | PATHFAST HSCRP | March 9, 2009 |
| K083040 | alfa wassermann diagnostic technologies | S-TEST C-REACTIVE PROTEIN (CRP) | January 30, 2009 |
| K072658 | siemens medical solutions diagnostics | ADVIA CHEMISTRY C-REACTIVE PROTEIN_2, (CRP_2) AND CALIBRATORS | April 1, 2008 |
| K073277 | roche diagnostics | ROCHE-CREACTIVE PROTEIN (LATEX) | March 6, 2008 |
| K062981 | boditech diagnostics | I-CHROMA CRP TEST | July 13, 2007 |
| K061825 | dade behring | DIMENSION VISTA CRP FLEX REAGENT CARTRIDGE, PROTEIN 2 CALIBRATOR, CONTROL LOW A | September 6, 2006 |
| K050713 | good biotech | DUET HS-CRP LIT ASSAY, CATALOG NUMBER: 4010, DUET HS-CRP CALIBRATOR SET, CATALO | June 6, 2005 |
| K040030 | biocheck | BIOCHECK CARDIAC-1 CRP RAPID TEST, MODEL BC-804114 | June 16, 2004 |
| K032336 | roche diagnostics | TINA-QUANT CRP (LATEX) | August 5, 2003 |
| K030899 | abbott laboratories | C-REACTIVE PROTEIN (CRP) | July 2, 2003 |