The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Tina-quant Transferrin Ver.2.
| Device ID | K012371 |
| 510k Number | K012371 |
| Device Name: | TINA-QUANT TRANSFERRIN VER.2 |
| Classification | Transferrin, Antigen, Antiserum, Control |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 -0457 |
| Contact | Sherri L Coenen |
| Correspondent | Sherri L Coenen ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 -0457 |
| Product Code | DDG |
| CFR Regulation Number | 866.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-26 |
| Decision Date | 2001-09-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613336121573 | K012371 | 000 |
| 04015630921317 | K012371 | 000 |
| 04015630917440 | K012371 | 000 |
| 04015630917426 | K012371 | 000 |