510(k) K193132 ยท LCX Kit, Test, Pregnancy, Hcg, Over The Counter
CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test Strip, CLUNGENE HCG Pregnancy Rapid Test Midstream
| Applicant | Hangzhou Clongene Biotech Co., Ltd., Hangzhou, CN |
| Decision | Substantially Equivalent, Dec 11, 2019 |
| Received | Nov 12, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193132
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.