510(k) K953383 ยท JHI Visual, Pregnancy Hcg, Prescription Use
WYNTEK OSOM HCG-URINE TEST
| Applicant | Wyntek Diagnostics, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Aug 29, 1995 |
| Received | Jul 19, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K953383
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.