510(k) K954178 ยท LCX Kit, Test, Pregnancy, Hcg, Over The Counter
OSOM PREGNANCY TEST
| Applicant | Wyntek Diagnostics, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Oct 23, 1995 |
| Received | Sep 5, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K954178
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.