510(k) K133851 ยท MYI System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies
ALERE PBP2A SA/CONS CULTURE COLONY TEST
| Applicant | Alere Scarborough, Inc., Scarborough ME, US |
| Decision | Substantially Equivalent, Sep 3, 2014 |
| Received | Dec 19, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133851
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.