510(k) Report

Devices descending from K180349

1 later device reach AssureTech Panel Dip Tests, AssureTech Quick Cup Tests through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190412CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy CupHangzhou Clongene Biotech Co., Ltd.20190—