510(k) K133637 ยท PSZ Devices Detecting Influenza A, B, And C Virus Antigens
ALERE INFLUENZA A & B TEST
| Applicant | Alere Scarborough, Inc D/B/A Binax, Inc., Scarborough ME, US |
| Decision | Substantially Equivalent, Dec 18, 2013 |
| Received | Nov 7, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K133637
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.