510(k) K821676 ยท JHJ Agglutination Method, Human Chorionic Gonadotropin
PREG-PHILE B
| Applicant | Bio Diagnostic Systems, Inc., Walker MI, US |
| Decision | Substantially Equivalent, Jul 16, 1982 |
| Received | Jun 8, 1982 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K821676
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.