510(k) K891581 ยท LEG Enzyme Immunoassay, Valproic Acid
COBAS-FP REAGENT FOR VALPROIC ACID & CALIBRATORS
| Applicant | Roche Diagnostic Systems, Inc., Montclair NJ, US |
| Decision | Substantially Equivalent, Aug 15, 1989 |
| Received | Mar 20, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K891581
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.