The following data is part of a premarket notification filed by Roche Diagnostic Systems, Inc. with the FDA for Cobas Fp Reagent Application For Free Valproic Acid.
| Device ID | K953224 |
| 510k Number | K953224 |
| Device Name: | COBAS FP REAGENT APPLICATION FOR FREE VALPROIC ACID |
| Classification | Enzyme Immunoassay, Valproic Acid |
| Applicant | ROCHE DIAGNOSTIC SYSTEMS, INC. 1080 U.S. HIGHWAY 202 Branchburg, NJ 08876 -1760 |
| Contact | Rita Smith |
| Correspondent | Rita Smith ROCHE DIAGNOSTIC SYSTEMS, INC. 1080 U.S. HIGHWAY 202 Branchburg, NJ 08876 -1760 |
| Product Code | LEG |
| CFR Regulation Number | 862.3645 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-13 |
| Decision Date | 1995-10-30 |