510(k) K210341 ยท LCX Kit, Test, Pregnancy, Hcg, Over The Counter
One Step Pregnancy Test
| Applicant | Spd Swiss Precision Diagnostics GmbH, Geneva, CH |
| Decision | Substantially Equivalent, Mar 10, 2022 |
| Received | Feb 5, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K210341
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.