510(k) K112177 ยท PSZ Devices Detecting Influenza A, B, And C Virus Antigens
SOFIA ANALYZER AND INFLUENZA A+B FIA
| Applicant | Quidel Corp., San Diego CA, US |
| Decision | Substantially Equivalent, Oct 24, 2011 |
| Received | Jul 28, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112177
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 14, 2013 | Quidel Corporation Quidel, Sofia Influenza A + B FIA, Kit #20218 (25-Test Kit), in vitro diagnostic. Terminated |
GNX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.