510(k) K183097 ยท LCX Kit, Test, Pregnancy, Hcg, Over The Counter
Kangzhou One Step hCG Test Strip, Kangzhou One Step hCG Test Cassette, Kangzhou One Step hCG Test Midstream
| Applicant | Weihai Kangzhou Biotechnology Engineering Co., Ltd., Weihai City, CN |
| Decision | Substantially Equivalent, Jan 10, 2019 |
| Received | Nov 7, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183097
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.