510(k) K212418 ยท LCX Kit, Test, Pregnancy, Hcg, Over The Counter
hCG One Step Pregnancy Test
| Applicant | Healstone Biotech, Inc., Vancouver, CA |
| Decision | Substantially Equivalent, Jun 30, 2022 |
| Received | Aug 3, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212418
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.