510(k) K061769 ยท LCX Kit, Test, Pregnancy, Hcg, Over The Counter
E.P.T. CERTAINTY 1-STEP PREGNANCY TEST
| Applicant | Unipath , Ltd., Bedford, GB |
| Decision | Substantially Equivalent, Jul 3, 2006 |
| Received | Jun 23, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K061769
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.