510(k) K860945 ยท JHJ Agglutination Method, Human Chorionic Gonadotropin
DIRECTACLONE CG SLIDE PREGNANCY TEST
| Applicant | Pacific Biotech, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, May 2, 1986 |
| Received | Mar 12, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K860945
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.