510(k) K983379 ยท LCO Platelet Factor 4 Radioimmunoassay
GTI-PF4 ELISA
| Applicant | Genetic Testing Institute, Brookfield WI, US |
| Decision | Substantially Equivalent, Mar 9, 1999 |
| Received | Sep 25, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983379
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.