510(k) K193318 · LCX Kit, Test, Pregnancy, Hcg, Over The Counter
Distinct® Early Detection Pregnancy Test
| Applicant | ACON Laboratories, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Aug 20, 2020 |
| Received | Dec 2, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193318
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.