510(k) K891095 ยท DHA System, Test, Human Chorionic Gonadotropin
VIS-DISK HCG (EIA) LYOPHILIZED JPL-044M
| Applicant | Leeco Diagnostics, Inc., Southfield MI, US |
| Decision | Substantially Equivalent, Jun 16, 1989 |
| Received | Mar 2, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K891095
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.