510(k) K974425 ยท DHA System, Test, Human Chorionic Gonadotropin
BIOSIGN HCG-ONE STEP PREGNANCY TEST, ACCUSIGN HCG-ONE STEP PREGNANCY TEST, LIFESIGN HCG-ONE STEP PREGNANCY TEST
| Applicant | Princeton BioMeditech Corp., Monmouth Junction NJ, US |
| Decision | Substantially Equivalent, Dec 24, 1997 |
| Received | Nov 24, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974425
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.