The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Tina-quant Cystatin C, Calibrator F.a.s. Cystatin C And Cystatin C Andcystatin C Control Set.
| Device ID | K080811 |
| 510k Number | K080811 |
| Device Name: | TINA-QUANT CYSTATIN C, CALIBRATOR F.A.S. CYSTATIN C AND CYSTATIN C ANDCYSTATIN C CONTROL SET |
| Classification | Test, Cystatin C |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Contact | Kerwin L Kaufman |
| Correspondent | Kerwin L Kaufman ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| 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 | 2008-03-24 |
| Decision Date | 2008-06-20 |
| Summary: | summary |