510(k) K141775 ยท GTY Antigens, All Groups, Streptococcus Spp.
SOFIA (R) STREP A+ FIA
| Applicant | Quidel Corporation, San Diego CA, US |
| Decision | Substantially Equivalent, Dec 16, 2014 |
| Received | Jul 1, 2014 |
| Type | Dual Track |
| FDA record | Open on fda.gov |
Recalls that name K141775
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 26, 2022 | Mckesson Medical-Surgical Inc. Corporate Office Strep test:
a. McKesson Medical-Surgical McKesson Rapid Test Kit McKesson Consult Infectious Disease Immunoassay Strep A Test Throat / Tonsil Saliva Sample 25 Tests, Model Number: 5003.
b. QUIDEL Open, Classified |
GTY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.