510(k) K974060 ยท JHI Visual, Pregnancy Hcg, Prescription Use
MINISTRIP/ SERUM AND URINE COMBO HCG TEST
| Applicant | International Newtech Development, Inc., Delta, B.C., CA |
| Decision | Substantially Equivalent, Apr 9, 1998 |
| Received | Oct 27, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974060
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.