510(k) K973879 ยท JHI Visual, Pregnancy Hcg, Prescription Use
OSOM CARD HCG-URINE TEST
| Applicant | Wyntek Diagnostics, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Nov 4, 1997 |
| Received | Sep 10, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973879
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.