510(k) K880678 ยท DHA System, Test, Human Chorionic Gonadotropin
MODIFIED VENTRESCREEN BETA HCG ENZYME IMMUNOASSAY
| Applicant | Ventrex Laboratories, Inc., Portland ME, US |
| Decision | Substantially Equivalent, Apr 5, 1988 |
| Received | Feb 19, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K880678
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.