The following data is part of a premarket notification filed by Roche Diagnostic Systems, Inc. with the FDA for Cobas Fp Reagen For Primidone & Primi Calibrators.
| Device ID | K852318 |
| 510k Number | K852318 |
| Device Name: | COBAS FP REAGEN FOR PRIMIDONE & PRIMI CALIBRATORS |
| Classification | Fluorescent Immunoassay, Primidone |
| Applicant | ROCHE DIAGNOSTIC SYSTEMS, INC. DIV. OF HOFFMANN-LA ROCHE, INC Nutley, NJ 07110 |
| Contact | Donald Kafader |
| Correspondent | Donald Kafader ROCHE DIAGNOSTIC SYSTEMS, INC. DIV. OF HOFFMANN-LA ROCHE, INC Nutley, NJ 07110 |
| Product Code | LFT |
| CFR Regulation Number | 862.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-31 |
| Decision Date | 1985-06-25 |