510(k) K102286 ยท GMD Antisera, Latex Agglutination, Cryptococcus Neoformans
CRAG LATERAL FLOW ASSAY (CRAG LFA)
| Applicant | Immuno-Mycologics, Inc., Norman OK, US |
| Decision | Substantially Equivalent, Jul 20, 2011 |
| Received | Aug 12, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K102286
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.