510(k) Report

Devices descending from K113208

9 later devices reach Gal-1A Blood Glucose Monitoring System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213887GAL-1A Plus Blood Glucose Monitoring SystemApex BioTechnology Corp.20220—
+1K141036BGM009 Blood Glucose Monitoring SystemApex BioTechnology Corp.20153—
+1K131750Autosure HT Blood Glucose Monitoring SystemApex BioTechnology Corp.20143—
+2K170267BGM009 Plus Blood Glucose Monitoring SystemApex BioTechnology Corp.20172—
+2K161299BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring SystemApex BioTechnology Corp.20162—
+3K222234GlucoSure ADVANCE Link Blood Glucose Monitoring SystemApex BioTechnology Corp.20220—
+3K202885GlucoSure HT Plus Blood Glucose Monitoring SystemApex BioTechnology Corp.20211—
+3K182992BGM014 Blood Glucose Monitoring SystemApex BioTechnology Corp.20180—
+4K220421BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring SystemApex BioTechnology Corp.20220—