510(k) K162438 ยท PSZ Devices Detecting Influenza A, B, And C Virus Antigens
Sofia Influenza A+B FIA on Sofia 2
| Applicant | Quidel Corporation, San Diego, CA, US |
| Decision | Substantially Equivalent, Apr 14, 2017 |
| Received | Aug 31, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162438
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 15, 2017 | Quidel Corporation Sofia 2 Analyzer Catalog Number 20299
Sofia 2 is a bench top analyzer intended to be used with Cassette-based immunofluorescent in vitro diagnostic assays . Sofia 2 is intended for professional and Terminated |
PSZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.