The following data is part of a premarket notification filed by Roche Diagnostic Systems, Inc. with the FDA for Modified Cobas Fp Reagents For Napa And Calibrator.
| Device ID | K871680 |
| 510k Number | K871680 |
| Device Name: | MODIFIED COBAS FP REAGENTS FOR NAPA AND CALIBRATOR |
| Classification | Enzyme Immunoassay, N-acetylprocainamide |
| Applicant | ROCHE DIAGNOSTIC SYSTEMS, INC. DIV. OF HOFFMANN-LA ROCHE, INC Nutley, NJ 07110 |
| Contact | Kafader Ii |
| Correspondent | Kafader Ii ROCHE DIAGNOSTIC SYSTEMS, INC. DIV. OF HOFFMANN-LA ROCHE, INC Nutley, NJ 07110 |
| Product Code | LAN |
| CFR Regulation Number | 862.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-29 |
| Decision Date | 1987-06-08 |