510(k) K953224 ยท LEG Enzyme Immunoassay, Valproic Acid
COBAS FP REAGENT APPLICATION FOR FREE VALPROIC ACID
| Applicant | Roche Diagnostic Systems, Inc., Branchburg NJ, US |
| Decision | Substantially Equivalent, Oct 30, 1995 |
| Received | Jun 13, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K953224
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.