510(k) K971122 ยท JHI Visual, Pregnancy Hcg, Prescription Use
ACCULINE PREGNANCY TEST
| Applicant | Genix Biotek, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Apr 25, 1997 |
| Received | Mar 27, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971122
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.