510(k) K081231 ยท DLZ Enzyme Immunoassay, Phenobarbital
ARCHITECT IPHENOBARBITAL REAGENTS AND ARCHITECT IPHENOBARBITAL CALIBRATORS, MODELS 1P33, 1P33
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Sep 26, 2008 |
| Received | May 1, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081231
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.