510(k) K250117 ยท LCX Kit, Test, Pregnancy, Hcg, Over The Counter
FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette
| Applicant | Assure Tech., LLC, Wilmington DE, US |
| Decision | Substantially Equivalent, Feb 13, 2025 |
| Received | Jan 16, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250117
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.