510(k) K212447 ยท LCX Kit, Test, Pregnancy, Hcg, Over The Counter
SEJOY hCG One Step Pregnancy Test Strip, SEJOY hCG One Step Pregnancy Test Cassette, SEJOY hCG One Step Pregnancy Test Midstream
| Applicant | Hangzhou Sejoy Electronics & Instruments Co., Ltd., Hangzhou City, CN |
| Decision | Substantially Equivalent, Feb 18, 2022 |
| Received | Aug 5, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212447
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.