510(k) K101407 ยท MIZ Enzyme Linked Immunoabsorbent Assay, Histoplasma Capsulatum
ALPHA HISTOPLASMA ANTIGEN EIA MODEL HAG102
| Applicant | Immuno-Mycologics, Inc., Norman OK, US |
| Decision | Substantially Equivalent, Jul 19, 2011 |
| Received | May 19, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101407
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.