K192072 is an FDA 510(k) clearance for the Tina-quant C-Reactive Protein IV. This device is classified as a System, Test, C-reactive Protein (Class II - Special Controls, product code DCN).
Submitted by Roche Diagnostics Operations (Rdo) (Indianapolis, US). The FDA issued a Cleared decision on February 21, 2020, 203 days after receiving the submission on August 2, 2019.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5270.
| 510(k) Number | K192072 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 02, 2019 |
| Decision Date | February 21, 2020 |
| Days to Decision | 203 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | DCN — System, Test, C-reactive Protein |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5270 |