The following data is part of a premarket notification filed by Roche Diagnostic Systems, Inc. with the FDA for Cobas Fp Reagents For Quinidine.
| Device ID | K850808 |
| 510k Number | K850808 |
| Device Name: | COBAS FP REAGENTS FOR QUINIDINE |
| Classification | Enzyme Immunoassay, Quinidine |
| Applicant | ROCHE DIAGNOSTIC SYSTEMS, INC. 11 FRANKLIN AVE. Belleville, NJ 07109 -3597 |
| Contact | Donald Kafader |
| Correspondent | Donald Kafader ROCHE DIAGNOSTIC SYSTEMS, INC. 11 FRANKLIN AVE. Belleville, NJ 07109 -3597 |
| Product Code | LBZ |
| CFR Regulation Number | 862.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-27 |
| Decision Date | 1985-03-25 |