510(k) K811940 ยท JHJ Agglutination Method, Human Chorionic Gonadotropin
OREIA II, B-HCG
| Applicant | Organon, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Aug 3, 1981 |
| Received | Jul 6, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K811940
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.