The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Cobas C Tina-quant Cystatin C Gen.2 Assay, C.f.a.s. Cystatin C Calibrator, Cystatin C Gen.2 Control Set.
| Device ID | K141143 |
| 510k Number | K141143 |
| Device Name: | COBAS C TINA-QUANT CYSTATIN C GEN.2 ASSAY, C.F.A.S. CYSTATIN C CALIBRATOR, CYSTATIN C GEN.2 CONTROL SET |
| Classification | Test, Cystatin C |
| Applicant | Roche Diagnostics 9115 HAGUE ROAD Indianapolis, IN 46250 -0416 |
| Contact | Khoa Tran |
| Correspondent | Khoa Tran Roche Diagnostics 9115 HAGUE ROAD Indianapolis, IN 46250 -0416 |
| Product Code | NDY |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-02 |
| Decision Date | 2014-07-17 |
| Summary: | summary |