The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Tina-quant Apolipoprotein B Ver.2.
| Device ID | K013207 |
| 510k Number | K013207 |
| Device Name: | TINA-QUANT APOLIPOPROTEIN B VER.2 |
| Classification | Lipoprotein, Low-density, Antigen, Antiserum, Control |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46256 |
| Contact | Kay A Taylor |
| Correspondent | Kay A Taylor ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46256 |
| Product Code | DFC |
| CFR Regulation Number | 866.5600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-25 |
| Decision Date | 2001-11-13 |
| Summary: | summary |