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Apex BioTechnology Corp.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
35
Inspections
2
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K242209UASure II Blood Uric Acid Monitoring SystemApril 4, 2025
K222234GlucoSure ADVANCE Link Blood Glucose Monitoring SystemDecember 21, 2022
K220421BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring SystemNovember 4, 2022
K212140GlucoSure Link Blood Glucose Monitoring SystemAugust 25, 2022
K202534MTM301 Blood Glucose and Ketone Monitoring SystemApril 6, 2022
K213887GAL-1A Plus Blood Glucose Monitoring SystemMarch 29, 2022
K201880MultiSure GK Link Blood Glucose and Ketone Monitoring SystemOctober 15, 2021
K202885GlucoSure HT Plus Blood Glucose Monitoring SystemSeptember 15, 2021
K182593KET-1 Blood Ketone Monitoring SystemDecember 18, 2018
K182992BGM014 Blood Glucose Monitoring SystemNovember 28, 2018
K170267BGM009 Plus Blood Glucose Monitoring SystemMarch 9, 2017
K161299BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring SystemDecember 23, 2016
K150396Autosure Voice II Blood Glucose Monitoring System, Autosure Voice II Pro Blood Glucose Monitoring SyOctober 14, 2015
K142689GAL-1F Blood Glucose Monitoring System, GAL-1F Pro Blood Glucose Monitoring SystemAugust 6, 2015
K143750MEG-2B Blood Glucose Monitoring System, MEG-2B Pro Blood Glucose Monitoring SystemMay 7, 2015
K141036BGM009 BLOOD GLUCOSE MONITORING SYSTEMMay 1, 2015
K131750AUTOSURE HT BLOOD GLUCOSE MONITORING SYSTEMMarch 6, 2014
K120649AUTOSURE VOICE 3 PLUS BLOOD GLUCOSE MONITORING SYSTEMJuly 6, 2012
K120448MEG-2B BLOOD GLUCOSE MONITORING SYSTEM, PRO BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE TEST STRIApril 6, 2012
K113547GAL-1E BLOOD GLUCOSE MONITORING SYSTEM GAL-1E BLOOD GLUCOSE TEST STRIPS GAL-1E MULTI BLOOD GLUCOSE MMarch 28, 2012