510(k) K010301 ยท LSE Epstein-Barr Virus, Other
IMMUNOWELL EA (D) IGG TEST
| Applicant | Genbio, San Diego CA, US |
| Decision | Substantially Equivalent, Jun 11, 2001 |
| Received | Feb 1, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010301
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.