The following data is part of a premarket notification filed by Roche Diagnostic Systems, Inc. with the FDA for Cobas-fp Reagent For Phenytoin And Coba-fp Phenytoin Calibrators.
| Device ID | K936131 |
| 510k Number | K936131 |
| Device Name: | COBAS-FP REAGENT FOR PHENYTOIN AND COBA-FP PHENYTOIN CALIBRATORS |
| Classification | Fluorescence Polarization Immunoassay, Diphenylhydantoin (total) |
| 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 | LGR |
| CFR Regulation Number | 862.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-23 |
| Decision Date | 1994-03-11 |