510(k) K120946 ยท MDU Antigen, Elisa, Cryptococcus
ALPHA CRYPTOCOCCAL ANTIGEN EIA
| Applicant | Immuno-Mycologics, Inc., Norman OK, US |
| Decision | Substantially Equivalent, Dec 17, 2012 |
| Received | Mar 29, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K120946
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.