510(k) K853247 ยท JHJ Agglutination Method, Human Chorionic Gonadotropin
ACU-SLIDE-TEST
| Applicant | Cal-Tech Diagnostics, Inc., Monterey Park CA, US |
| Decision | Substantially Equivalent, Sep 4, 1985 |
| Received | Aug 1, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K853247
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.