510(k) K132465 ยท PSZ Devices Detecting Influenza A, B, And C Virus Antigens
BIOSIGN FLU A + B, STATUS FLU A & B
| Applicant | Princeton BioMeditech Corp., Monmouth Junction NJ, US |
| Decision | Substantially Equivalent, Sep 9, 2013 |
| Received | Aug 7, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K132465
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.