510(k) K251053 ยท LCX Kit, Test, Pregnancy, Hcg, Over The Counter
Shinetell PlusTM Digital Early Pregnancy Test
| Applicant | Hangzhou AllTest Biotech Co., Ltd., Hangzhou, CN |
| Decision | Substantially Equivalent, Jul 15, 2025 |
| Received | Apr 4, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251053
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.