The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Tina-quant Apolipoprotein Ver.2.
| Device ID | K013249 |
| 510k Number | K013249 |
| Device Name: | TINA-QUANT APOLIPOPROTEIN VER.2 |
| Classification | Alpha-1-lipoprotein, Antigen, Antiserum, Control |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46256 |
| Contact | Helen T Torney |
| Correspondent | Helen T Torney ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46256 |
| Product Code | DER |
| CFR Regulation Number | 866.5580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-28 |
| Decision Date | 2001-11-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613336133521 | K013249 | 000 |