ClearanceBrief
510(k) K011679 ยท POV Semen Analysis Device

FERTILMARQ HOME DIAGNOSTIC SCREENING TEST KIT FOR MALE INFERTILITY

ApplicantEmbryotech Laboratories, Inc., Wayland MA, US
DecisionSubstantially Equivalent, Aug 15, 2001
ReceivedMay 30, 2001
TypeTraditional
FDA recordOpen 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.