510(k) Report

Devices descending from K972868

1 later device reach Trademark Blood Gas/Electrolyte/Glucose, Lactate, Bun and Creatinine Control 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—