510(k) K083744 ยท MJZ Kit, Direct Antigen, Positive Control
BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010
| Applicant | Binax, Inc., Scarborough ME, US |
| Decision | Substantially Equivalent, Sep 1, 2009 |
| Received | Dec 16, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083744
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.