510(k) K150063 ยท LCX Kit, Test, Pregnancy, Hcg, Over The Counter
One Step hCG Pregnancy Test
| Applicant | Coretests, Inc., Carlsbad CA, US |
| Decision | Substantially Equivalent, Oct 2, 2015 |
| Received | Jan 13, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150063
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.