510(k) K965227 ยท JHI Visual, Pregnancy Hcg, Prescription Use
OSOM CLASSIC HCG-URINE TEST (115)
| Applicant | Wyntek Diagnostics, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Feb 4, 1997 |
| Received | Dec 30, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K965227
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.