510(k) K841525 ยท JHI Visual, Pregnancy Hcg, Prescription Use
OREIA II B-HCG PREGNANCY TEST KIT
| Applicant | Organon, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Jun 5, 1984 |
| Received | Apr 12, 1984 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K841525
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.