The following data is part of a premarket notification filed by Roche Diagnostics Operations (rdo) with the FDA for Tina-quant Cystatin C Gen.2.
| Device ID | K161817 |
| 510k Number | K161817 |
| Device Name: | Tina-quant Cystatin C Gen.2 |
| Classification | Test, Cystatin C |
| Applicant | Roche Diagnostics Operations (RDO) 9115 Hague Road Indianapolis, IN 46250 |
| Contact | Patrick Stimart |
| Correspondent | Patrick Stimart Roche Diagnostics Operations (RDO) 9115 Hague Road Indianapolis, IN 46250 |
| Product Code | NDY |
| CFR Regulation Number | 862.1225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-01 |
| Decision Date | 2016-07-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613336133644 | K161817 | 000 |