510(k) K080696 ยท DIP Enzyme Immunoassay, Diphenylhydantoin
ARCHITECT IPHENYTOIN REAGENTS AND ARCHITECH IPHENYTOIN CALIBRATORS WITH MODELS 1P34, AND 1P34-01
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Sep 11, 2008 |
| Received | Mar 12, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080696
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.