K161817 is an FDA 510(k) clearance for the Tina-quant Cystatin C Gen.2. This device is classified as a Test, Cystatin C (Class II - Special Controls, product code NDY).
Submitted by Roche Diagnostics Operations (Rdo) (Indianapolis, US). The FDA issued a Cleared decision on July 27, 2016, 26 days after receiving the submission on July 1, 2016.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1225.
| 510(k) Number | K161817 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 01, 2016 |
| Decision Date | July 27, 2016 |
| Days to Decision | 26 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | NDY — Test, Cystatin C |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1225 |