510(k) K090358 ยท LEG Enzyme Immunoassay, Valproic Acid
ARCHITECT IVALPROIC ACID REAGENTS AND ARCHITECT IVALPROIC ACID CALIBRATORS, MODELS 1P35, 1P35
| Applicant | Abbott Laboratories, Inc., Abbott Park IL, US |
| Decision | Substantially Equivalent, Aug 6, 2009 |
| Received | Feb 12, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K090358
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.