510(k) K192843 ยท LCX Kit, Test, Pregnancy, Hcg, Over The Counter
INNOVITA HCG Pregnancy Rapid Test Strip, INNOVITA HCG Pregnancy Rapid Test Cassette, INNOVITA HCG Pregnancy Rapid Test Midstream
| Applicant | Innovita (Tangshan) Biological Technology Co., Ltd., Qian'An, CN |
| Decision | Substantially Equivalent, Nov 22, 2019 |
| Received | Oct 3, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192843
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.