510(k) K121905 ยท MYI System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies
ALERE PBP2A TEST
| Applicant | Alere Scarborough, Inc., Scarborough ME, US |
| Decision | Substantially Equivalent, Jul 26, 2012 |
| Received | Jun 29, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K121905
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.