Apex BioTechnology Corp. - FDA 510(k) Cleared Devices
Recent clearances: UASure II Blood Uric Acid Monitoring System, GlucoSure ADVANCE Link Blood Glucose Monitoring System, BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring System
35
Total
35
Cleared
0
Denied
FDA 510(k) Regulatory Record - Apex BioTechnology Corp. Chemistry ✕
35 devices
Cleared
Apr 04, 2025
UASure II Blood Uric Acid Monitoring System
Chemistry
249d
Cleared
Dec 21, 2022
GlucoSure ADVANCE Link Blood Glucose Monitoring System
Chemistry
148d
Cleared
Nov 04, 2022
BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring...
Chemistry
263d
Cleared
Aug 25, 2022
GlucoSure Link Blood Glucose Monitoring System
Chemistry
413d
Cleared
Apr 06, 2022
MTM301 Blood Glucose and Ketone Monitoring System
Chemistry
582d
Cleared
Mar 29, 2022
GAL-1A Plus Blood Glucose Monitoring System
Chemistry
106d
Cleared
Oct 15, 2021
MultiSure GK Link Blood Glucose and Ketone Monitoring System
Chemistry
465d
Cleared
Sep 15, 2021
GlucoSure HT Plus Blood Glucose Monitoring System
Chemistry
352d
Cleared
Dec 18, 2018
KET-1 Blood Ketone Monitoring System
Chemistry
89d
Cleared
Nov 28, 2018
BGM014 Blood Glucose Monitoring System
Chemistry
30d
Cleared
Mar 09, 2017
BGM009 Plus Blood Glucose Monitoring System
Chemistry
41d
Cleared
Dec 23, 2016
BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring...
Chemistry
228d