510(k) K973414 ยท DIP Enzyme Immunoassay, Diphenylhydantoin
ACE PHENYTOIN REAGENT, AED CALIBRATORS
| Applicant | Schiapparelli Biosystems, Inc., Fairfield NJ, US |
| Decision | Substantially Equivalent, Nov 4, 1997 |
| Received | Sep 9, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973414
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.