510(k) K233174 · LCX Kit, Test, Pregnancy, Hcg, Over The Counter
FaStep Pregnancy Rapid Test Strip; FaStep Pregnancy Rapid Test Midstream
| Applicant | Assure Tech. (Hangzhou) Co, Ltd., Hangzhou, CN |
| Decision | Substantially Equivalent, Feb 5, 2024 |
| Received | Sep 28, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K233174
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.