510(k) K200133 ยท LCX Kit, Test, Pregnancy, Hcg, Over The Counter
hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream
| Applicant | Safecare Biotech (Hangzhou) Co., Ltd., Hangzhou, CN |
| Decision | Substantially Equivalent, Aug 13, 2020 |
| Received | Jan 21, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200133
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.