510(k) K973535 ยท KLT Enzyme Immunoassay, Carbamazepine
ACE CARBAMAZEPINE REAGENT/AED CALIBRATORS
| Applicant | Schiapparelli Biosystems, Inc., Fairfield NJ, US |
| Decision | Substantially Equivalent, Oct 20, 1997 |
| Received | Sep 18, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973535
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.