510(k) K011947 ยท LEG Enzyme Immunoassay, Valproic Acid
EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL
| Applicant | Syva Co., Cupertino CA, US |
| Decision | Substantially Equivalent, Jul 2, 2001 |
| Received | Jun 21, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K011947
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.