510(k) K192123 ยท LCX Kit, Test, Pregnancy, Hcg, Over The Counter
HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rapid Test Strip, HIGHTOP Pregnancy Rapid Test Midstream
| Applicant | Qingdao Hightop Biotech Co., Ltd., Qingdao, CN |
| Decision | Substantially Equivalent, Sep 5, 2019 |
| Received | Aug 6, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192123
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.