DCN — System, Test, C-Reactive Protein Class II
FDA product code DCN covers "System, Test, C-Reactive Protein", a Class II medical device regulated under 21 CFR 866.5270. Submissions are reviewed by the Immunology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |