The following data is part of a premarket notification filed by Roche Diagnostics Operations with the FDA for Tina-quant Albumin Gen.2.
| Device ID | K113072 |
| 510k Number | K113072 |
| Device Name: | TINA-QUANT ALBUMIN GEN.2 |
| Classification | Albumin, Antigen, Antiserum, Control |
| Applicant | ROCHE DIAGNOSTICS OPERATIONS 9115 Hague Rd Indianapolis, IN 46256 |
| Contact | Patrick Stimart |
| Correspondent | Patrick Stimart ROCHE DIAGNOSTICS OPERATIONS 9115 Hague Rd Indianapolis, IN 46256 |
| Product Code | DCF |
| CFR Regulation Number | 866.5040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-17 |
| Decision Date | 2012-05-14 |
| Summary: | summary |