510(k) K973582 ยท DJD Enzyme Immunoassay, Primidone
ACE PRIMIDONE REAGENT, AED CALIBRATORS
| Applicant | Schiapparelli Biosystems, Inc., Fairfield NJ, US |
| Decision | Substantially Equivalent, Nov 12, 1997 |
| Received | Sep 22, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973582
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.