510(k) K964536 ยท JHI Visual, Pregnancy Hcg, Prescription Use
ONE-STEP DIPSTICK PREGNANCY TEST
| Applicant | Teco Diagnostics, Anaheim CA, US |
| Decision | Substantially Equivalent, Feb 11, 1997 |
| Received | Nov 12, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964536
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.