510(k) K171976 ยท GTY Antigens, All Groups, Streptococcus Spp.
Sofia Strep A+ FIA, Sofia 2 Analyzer
| Applicant | Quidel Corporation, San Diego, CA, US |
| Decision | Substantially Equivalent, Dec 21, 2017 |
| Received | Jun 30, 2017 |
| Type | Dual Track |
| FDA record | Open on fda.gov |
Recalls that name K171976
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.