510(k) K213808 ยท LCX Kit, Test, Pregnancy, Hcg, Over The Counter
Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Strip, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Cassette, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Midstream
| Applicant | Co-Innovation Biotech Co., Ltd., Guangzhou, CN |
| Decision | Substantially Equivalent, Apr 5, 2022 |
| Received | Dec 6, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K213808
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.