510(k) K010582 ยท GTY Antigens, All Groups, Streptococcus Spp.
ACON STREP A RAPID TEST STRIP
| Applicant | Acon Laboratories Co., San Diego CA, US |
| Decision | Substantially Equivalent, May 7, 2001 |
| Received | Feb 27, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010582
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 18, 2025 | Mckesson Medical-Surgical Inc. Corporate Office Clearview Strep A Exact II Dipstick Respiratory Kit, CLIA Waived. Catalog Number: 4581225020 Open, Classified |
GTY | None listed |
| Sep 19, 2024 | Cypress Medical Products LLC Acceava Respiratory Strep A, CLIA Waived, Catalog Number 4580295008 Open, Classified |
GTY | None listed |
| 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.