510(k) K232864 ยท LCX Kit, Test, Pregnancy, Hcg, Over The Counter
EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II
| Applicant | Nantong Egens Biotechnology Co., Ltd., Nantong, CN |
| Decision | Substantially Equivalent, Jan 26, 2024 |
| Received | Sep 15, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K232864
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.