510(k) K964574 ยท JHI Visual, Pregnancy Hcg, Prescription Use
AFFIRM ONE-STEP PROFESSIONAL PREGNANCY TEST
| Applicant | Athena Medical Corp., Portland OR, US |
| Decision | Substantially Equivalent, Jan 21, 1997 |
| Received | Nov 14, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964574
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.