510(k) K881435 ยท JHJ Agglutination Method, Human Chorionic Gonadotropin
PREGNOSPIA II
| Applicant | Organon Teknika Corp., Durham NC, US |
| Decision | Substantially Equivalent, May 27, 1988 |
| Received | Apr 5, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K881435
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.