510(k) K925003 ยท LEG Enzyme Immunoassay, Valproic Acid
COBAS-FP REAGENT FOR VALPROIC ACID AND CALIBRATORS
| Applicant | Roche Diagnostic Systems, Inc., Branchburg NJ, US |
| Decision | Substantially Equivalent, Dec 3, 1992 |
| Received | Oct 2, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K925003
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.