510(k) K260342 ยท GTY Antigens, All Groups, Streptococcus Spp.
AllTest Strep A Rapid Test
| Applicant | Hangzhou AllTest Biotech Co., Ltd., Hangzhou, CN |
| Decision | Substantially Equivalent, Apr 30, 2026 |
| Received | Feb 2, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260342
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.