510(k) Report

Devices descending from K041202

1 later device reach Hemosure One-Step Fecal Occult Blood Test through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K063693Forsure One Step Fecal Occult Blood (Fob) Screen Card TestNew Bay Bioresearch Co., Ltd.200704