510(k) Report

Devices descending from K925479

6 later devices reach Sugar Chex Linearity for the One Touch through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K012430Multi-Meter Glucose Calibration Verification Material, Model Rna GL3Bionostics, Inc.20015—
+2K032819Glucose Control Solution for Chdiagnostics Senova, Chdignostics Senova Blood Glucose…Bionostics, Inc.20030—
+2K021624Rna GL4 Glucose Calibration Verification Control, Model Rna CVC GL4Bionostics, Inc.20021—
+2K021697Glucose Control Solution for BD LatitudeBionostics, Inc.20020—
+2K013147Glucose Control Solution for Therasense FreestyleBionostics, Inc.200101
+3K081478Rna Medical Glucose and B-Ketone Calibration Verification ControlsBionostics, Inc.20080—