510(k) K782166 ยท JHJ Agglutination Method, Human Chorionic Gonadotropin
SLIDE TEST FOR PREGNANCY, GRAVINDEX 90
| Applicant | Ortho Diagnostics, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Apr 4, 1979 |
| Received | Dec 29, 1978 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K782166
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.