510(k) K954901 ยท JHI Visual, Pregnancy Hcg, Prescription Use
BIONIKE A/Q PREGNANCY TEST
| Applicant | Bionike Laboratories, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Dec 11, 1995 |
| Received | Oct 25, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K954901
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.