510(k) K861212 ยท JHJ Agglutination Method, Human Chorionic Gonadotropin
DIRECT ACU-SLIDE TEST
| Applicant | Cal-Tech Diagnostics, Inc., Monterey Park CA, US |
| Decision | Substantially Equivalent, Jul 7, 1986 |
| Received | Mar 31, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K861212
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.