510(k) K962888 ยท LCX Kit, Test, Pregnancy, Hcg, Over The Counter
AFFIRM ONE-STEP HOME PREGNANCY TEST
| Applicant | Athena Medical Corp., Portland OR, US |
| Decision | Substantially Equivalent, Sep 23, 1996 |
| Received | Jul 24, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K962888
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.