510(k) K162642 ยท PSZ Devices Detecting Influenza A, B, And C Virus Antigens
Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit
| Applicant | Alere Scarborough, Inc., Scarborough ME, US |
| Decision | Substantially Equivalent, Apr 10, 2017 |
| Received | Sep 22, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162642
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.