510(k) K911362 ยท LJN Antibody Igm, If, Epstein-Barr Virus
AMIZYME EPSTEIN-BARR VIRUS (EBV) IGM ANTIBODY TEST
| Applicant | Amico Laboratories, Inc., Nashville TN, US |
| Decision | Substantially Equivalent, Oct 7, 1991 |
| Received | Mar 28, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K911362
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.