510(k) K933997 ยท GMD Antisera, Latex Agglutination, Cryptococcus Neoformans
PROSPECT ENTAMOEBA HISTOLYTICA MICROPLATE ASSAY
| Applicant | Alexon Biomedical, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Nov 22, 1993 |
| Received | Aug 17, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K933997
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.