510(k) K912489 ยท LSE Epstein-Barr Virus, Other
COLORZYME EBV EARLY ANTIGEN IGG ANTIBODY TEST SYS
| Applicant | Immuno Concepts, Inc., Sacramento CA, US |
| Decision | Substantially Equivalent, Jul 24, 1991 |
| Received | Jun 4, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K912489
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.