510(k) K123793 ยท GTY Antigens, All Groups, Streptococcus Spp.
SOFIA STREP A FIA
| Applicant | Quidel Corporation, San Diego CA, US |
| Decision | Substantially Equivalent, Jun 17, 2013 |
| Received | Dec 10, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123793
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.