510(k) K153012 ยท PSZ Devices Detecting Influenza A, B, And C Virus Antigens
Sofia Influenza A+B FIA
| Applicant | Quidel Corporation, San Diego, CA, US |
| Decision | Substantially Equivalent, Jan 12, 2016 |
| Received | Oct 14, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153012
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.