K080811 is an FDA 510(k) clearance for the TINA-QUANT CYSTATIN C, CALIBRATOR F.A.S. CYSTATIN C AND CYSTATIN C ANDCYSTATIN C CONTROL SET. This device is classified as a Test, Cystatin C (Class II - Special Controls, product code NDY).
Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on June 20, 2008, 88 days after receiving the submission on March 24, 2008.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1225.
| 510(k) Number | K080811 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 24, 2008 |
| Decision Date | June 20, 2008 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| 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 |