510(k) Report

Devices descending from K223162

1 later device reach Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252523Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug TestHealgen Scientific,, LLC20260—