510(k) K241394 · LCX Kit, Test, Pregnancy, Hcg, Over The Counter
iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip
| Applicant | Andon Health Co, Ltd., Tianjin, CN |
| Decision | Substantially Equivalent, Dec 20, 2024 |
| Received | May 16, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K241394
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.