510(k) Report

Devices descending from K113547

1 later device reach Gal-1E Blood Glucose Monitoring System Gal-1E Blood Glucose Test Strips Gal-1E… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142689GAL-1F Blood Glucose Monitoring System, GAL-1F Pro Blood Glucose Monitoring SystemApex BioTechnology Corp.20150—