510(k) K981829 ยท GNP Antiserum, Cf, Epstein-Barr Virus
IS EBV-EBNA-1 IGG ELISA TEST SYSTEM
| Applicant | Diamedix Corp., Columbia MD, US |
| Decision | Substantially Equivalent, Feb 16, 1999 |
| Received | May 22, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981829
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.