The following data is part of a premarket notification filed by Roche Diagnostic Systems, Inc. with the FDA for Cobas(r)-fp Reagent For Procainamide/calibrator.
| Device ID | K942847 |
| 510k Number | K942847 |
| Device Name: | COBAS(R)-FP REAGENT FOR PROCAINAMIDE/CALIBRATOR |
| Classification | Enzyme Immunoassay, Procainamide |
| Applicant | ROCHE DIAGNOSTIC SYSTEMS, INC. 1080 U.S. HIGHWAY 202 Branchburg, NJ 08876 -1760 |
| Contact | Carol L Krieger |
| Correspondent | Carol L Krieger ROCHE DIAGNOSTIC SYSTEMS, INC. 1080 U.S. HIGHWAY 202 Branchburg, NJ 08876 -1760 |
| Product Code | LAR |
| CFR Regulation Number | 862.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-16 |
| Decision Date | 1994-12-02 |