K141143 is an FDA 510(k) clearance for the COBAS C TINA-QUANT CYSTATIN C GEN.2 ASSAY, C.F.A.S. CYSTATIN C CALIBRATOR, CYSTATIN C GEN.2 CONTROL SET. This device is classified as a Test, Cystatin C (Class II - Special Controls, product code NDY).
Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on July 17, 2014, 76 days after receiving the submission on May 2, 2014.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1225.
| 510(k) Number | K141143 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 02, 2014 |
| Decision Date | July 17, 2014 |
| Days to Decision | 76 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 |