510(k) K970387 ยท DHA System, Test, Human Chorionic Gonadotropin
HUMAN CHORIONIC GONADOTROPIN METHOD
| Applicant | Dade Chemistry Systems, Inc., Glasgow DE, US |
| Decision | Substantially Equivalent, Mar 10, 1997 |
| Received | Feb 3, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970387
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.