510(k) K181853 ยท PSZ Devices Detecting Influenza A, B, And C Virus Antigens
Alere BinaxNOW Influenza A & B Card 2, Alere Reader
| Applicant | Alere Scarborough, Inc., Scarborough ME, US |
| Decision | Substantially Equivalent, Aug 8, 2018 |
| Received | Jul 11, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K181853
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.