510(k) K011679 ยท POV Semen Analysis Device
FERTILMARQ HOME DIAGNOSTIC SCREENING TEST KIT FOR MALE INFERTILITY
| Applicant | Embryotech Laboratories, Inc., Wayland MA, US |
| Decision | Substantially Equivalent, Aug 15, 2001 |
| Received | May 30, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011679
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.