510(k) K090964 ยท JWX Kit, Screening, Staphylococcus Aureus
BINAXNOX STAPHYLOCOCCUS AUREUS TEST
| Applicant | Binax, Inc., Scarborough ME, US |
| Decision | Substantially Equivalent, Dec 16, 2009 |
| Received | Apr 6, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K090964
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.