510(k) Report

Devices descending from K862186

3 later devices reach Lyphochek Glycated Hemoglobin/Whole Blood/Lev.I&II through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K070546Lyphochek Diabetes ControlBio-Rad Laboratories20070—
+1K052838Liquichek Diabetes Control, Level 1,2,3,4Bio-Rad20051—
+2K123798Liquidchek Diabetes Control; Level 1, Level 2, Level 3, Trilevel MinipakBio-Rad Laboratories20130—