510(k) K951136 ยท JHI Visual, Pregnancy Hcg, Prescription Use
BIONIKE A/Q PREGNANCY TEST
| Applicant | Charlton Assoc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Apr 20, 1995 |
| Received | Mar 13, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K951136
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.