510(k) K990578 ยท JHI Visual, Pregnancy Hcg, Prescription Use
OSOM CARD II HCG-URINE TEST, MODEL 102
| Applicant | Wyntek Diagnostics, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Mar 9, 1999 |
| Received | Feb 23, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K990578
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.