510(k) K944426 ยท JHI Visual, Pregnancy Hcg, Prescription Use
BIOSIGN, ACCUSIGN, LIFESIGN, HCG SERUM/URINE
| Applicant | Princeton BioMeditech Corp., Monmouth Junction NJ, US |
| Decision | Substantially Equivalent, Oct 25, 1994 |
| Received | Sep 12, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K944426
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 30, 2024 | Princeton Biomeditech Corp Osom Ultra hCG Combo Test- IVD immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine for the early confirmation of pregnancy.
Model/Catalog Number: 1004 Open, Classified |
JHI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.