510(k) K092223 ยท PSZ Devices Detecting Influenza A, B, And C Virus Antigens
MODIFICATION TO: BINAXNOW INFLUENZA A & B TEST
| Applicant | Binax, Inc., Scarborough ME, US |
| Decision | Substantially Equivalent, Aug 12, 2009 |
| Received | Jul 23, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K092223
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.