510(k) Report

Devices descending from K001632

1 later device reach Opti-Check Plus Multi-Analyte Control, Model HC7009 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K012431Combitrol TS Multi Analyte Control, Levels 1,2,3, Autotrol TS Multi Analyte Control…Bionostics, Inc.20010—