510(k) K243573 ยท LCX Kit, Test, Pregnancy, Hcg, Over The Counter
FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test Midstream
| Applicant | Assure Tech., LLC, Wilmington DE, US |
| Decision | Substantially Equivalent, Jan 15, 2025 |
| Received | Nov 19, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243573
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.