510(k) K161364 ยท JBF Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening
BinaxNOW G6PD Test
| Applicant | Alere Scarborough, Inc., Scarborough ME, US |
| Decision | Substantially Equivalent, Jun 17, 2016 |
| Received | May 17, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K161364
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.