The following data is part of a premarket notification filed by Roche Diagnostics Operations (rdo) with the FDA for Tina-quant Transferrin Ver.2 (urine Application).
| Device ID | K182095 |
| 510k Number | K182095 |
| Device Name: | Tina-quant Transferrin Ver.2 (urine Application) |
| Classification | Transferrin, Antigen, Antiserum, Control |
| Applicant | Roche Diagnostics Operations (RDO) 9115 Hague Road Indianapolis, IN 46250 |
| Contact | Lindsay Jones |
| Correspondent | Lindsay Jones Roche Diagnostics Operations (RDO) 9115 Hague Road Indianapolis, IN 46250 |
| Product Code | DDG |
| CFR Regulation Number | 866.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-03 |
| Decision Date | 2018-11-05 |
| Summary: | summary |