510(k) K973941 ยท LLM Test, Antigen, Nuclear, Epstein-Barr Virus
IMMUNOWELL EBNA IGG TEST
| Applicant | Genbio, San Diego CA, US |
| Decision | Substantially Equivalent, Aug 10, 1998 |
| Received | Oct 15, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973941
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.