510(k) K954898 ยท GGT Assay, Erythropoietin
PREDICTA ERYTHROPOIETIN KIT (MODIFICATION)
| Applicant | Genzyme Corp., Cambridge MA, US |
| Decision | Substantially Equivalent, Feb 5, 1996 |
| Received | Sep 20, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K954898
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.