510(k) K242135 ยท LCX Kit, Test, Pregnancy, Hcg, Over The Counter
Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream
| Applicant | Nanjing Synthgene Medical Technology Co., Ltd., Nanjing, CN |
| Decision | Substantially Equivalent, Jan 31, 2025 |
| Received | Jul 22, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K242135
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.