510(k) K974009 ยท JHI Visual, Pregnancy Hcg, Prescription Use
PS-UNIT CASSETTE/SERUM AND URINE COMBO HCG
| Applicant | International Newtech Development, Inc., Delta, B.C., CA |
| Decision | Substantially Equivalent, Mar 13, 1998 |
| Received | Oct 21, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974009
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.