510(k) K080003 ยท JBF Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening
BINAXNOW G6PD TEST
| Applicant | Binax, Inc., Scarborough ME, US |
| Decision | Substantially Equivalent, Oct 23, 2008 |
| Received | Jan 2, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080003
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.