510(k) K090301 ยท MYI System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies
BINAXNOW PBP2A TEST, MODEL 890-000
| Applicant | Binax, Inc., Scarborough ME, US |
| Decision | Substantially Equivalent, Apr 14, 2010 |
| Received | Feb 6, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K090301
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.