510(k) Report

Devices descending from K102816

12 later devices reach Gal-1C Blood Glucose Monitoring System, Gal-1C Test Strips through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K113547Gal-1E Blood Glucose Monitoring System Gal-1E Blood Glucose Test Strips Gal-1E Multi…Apex BioTechnology Corp.20121—
+1K113208Gal-1A Blood Glucose Monitoring SystemApex BioTechnology Corp.20129—
+2K213887GAL-1A Plus Blood Glucose Monitoring SystemApex BioTechnology Corp.20220—
+2K142689GAL-1F Blood Glucose Monitoring System, GAL-1F Pro Blood Glucose Monitoring SystemApex BioTechnology Corp.20150—
+2K141036BGM009 Blood Glucose Monitoring SystemApex BioTechnology Corp.20153—
+2K131750Autosure HT Blood Glucose Monitoring SystemApex BioTechnology Corp.20143—
+3K170267BGM009 Plus Blood Glucose Monitoring SystemApex BioTechnology Corp.20172—
+3K161299BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring SystemApex BioTechnology Corp.20162—
+4K222234GlucoSure ADVANCE Link Blood Glucose Monitoring SystemApex BioTechnology Corp.20220—
+4K202885GlucoSure HT Plus Blood Glucose Monitoring SystemApex BioTechnology Corp.20211—
+4K182992BGM014 Blood Glucose Monitoring SystemApex BioTechnology Corp.20180—
+5K220421BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring SystemApex BioTechnology Corp.20220—