510(k) K832801 ยท JHI Visual, Pregnancy Hcg, Prescription Use
OREIA II B-HCG, ENZYME INNUNOASSAY
| Applicant | Organon, Inc., Walker MI, US |
| Decision | Substantially Equivalent, Dec 8, 1983 |
| Received | Aug 18, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K832801
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.