FDA 510(k) Applications Submitted by APEX BIOTECHNOLOGY CORP.

FDA 510(k) Number Submission Date Device Name Applicant
K011233 04/23/2001 MODIFICATION TO GLUCOSURE BGM SYSTEM, MODEL 221100 APEX BIOTECHNOLOGY CORP.
K062799 09/19/2006 GLUCO TRACK BLOOD GLUCOSE MONITORING SYSTEM APEX BIOTECHNOLOGY CORP.
K150396 02/18/2015 Autosure Voice II Blood Glucose Monitoring System, Autosure Voice II Pro Blood Glucose Monitoring System, Autosure Blood Glucose Test Strips, Autosure Pro Blood Glucose Test Strips APEX BIOTECHNOLOGY CORP.
K141036 04/22/2014 BGM009 BLOOD GLUCOSE MONITORING SYSTEM APEX BIOTECHNOLOGY CORP.
K101204 04/30/2010 MEG-2 BLOOD GLUCOSE MONITORING SYSTEM, MEG-2 50'S TEST STRIP, MEG-2 CONTROL SOLUTION APEX BIOTECHNOLOGY CORP.
K161299 05/09/2016 BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring System APEX BIOTECHNOLOGY CORP.
K131750 06/14/2013 AUTOSURE HT BLOOD GLUCOSE MONITORING SYSTEM APEX BIOTECHNOLOGY CORP.
K102037 07/19/2010 AUTOSURE VOICE II BLOOD GLUCOSE MONITORING SYSTEM AND TEST STRIPS APEX BIOTECHNOLOGY CORP.
K142689 09/22/2014 GAL-1F Blood Glucose Monitoring System, GAL-1F Pro Blood Glucose Monitoring System Apex BioTechnology Corp.
K102816 09/28/2010 GAL-1C BLOOD GLUCOSE MONITORING SYSTEM, GAL-1C TEST STRIPS APEX BIOTECHNOLOGY CORP.
K113098 10/19/2011 AUTOSURE VOICE II PLUS, AUTOSURE PLUS BLOOD GLUCOSE TEST STRIPS,CONTREX PLUS III APEX BIOTECHNOLOGY CORP.
K113208 11/01/2011 GAL-1A BLOOD GLUCOSE MONITORING SYSTEM APEX BIOTECHNOLOGY CORP.
K113547 12/01/2011 GAL-1E BLOOD GLUCOSE MONITORING SYSTEM GAL-1E BLOOD GLUCOSE TEST STRIPS GAL-1E MULTI BLOOD GLUCOSE MONITORING SYSTEM GAL APEX BIOTECHNOLOGY CORP.
K120448 02/14/2012 MEG-2B BLOOD GLUCOSE MONITORING SYSTEM, PRO BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE TEST STRIPS, GLUCOSE CONTROL APEX BIOTECHNOLOGY CORP.
K220421 02/14/2022 BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring System Apex BioTechnology Corp.
K212140 07/08/2021 GlucoSure Link Blood Glucose Monitoring System Apex Biotechnology Corp.
K222234 07/26/2022 GlucoSure ADVANCE Link Blood Glucose Monitoring System Apex BioTechnology Corp.
K102481 08/30/2010 AUTOSURE VOICE 3 BLOOD GLUCOSE MONITORING SYSTEM AND TEST STRIP APEX BIOTECHNOLOGY CORP.
K202534 09/01/2020 MTM301 Blood Glucose and Ketone Monitoring System Apex Biotechnology Corp.
K182593 09/20/2018 KET-1 Blood Ketone Monitoring System Apex Biotechnology Corp.
K202885 09/28/2020 GlucoSure HT Plus Blood Glucose Monitoring System Apex BioTechnology Corp.
K182992 10/29/2018 BGM014 Blood Glucose Monitoring System Apex Biotechnology Corp.
K213887 12/13/2021 GAL-1A Plus Blood Glucose Monitoring System Apex BioTechnology Corp.
K201880 07/07/2020 MultiSure GK Link Blood Glucose and Ketone Monitoring System Apex Biotechnology Corp.
K002621 08/23/2000 GLUCOSURE BLOOD GLUCOSE MONITORING SYSTEM APEX BIOTECHNOLOGY CORP.
K002624 08/23/2000 GLUCOSMART BLOOD GLUCOSE MONITORING SYSTEM APEX BIOTECHNOLOGY CORP.
K073137 11/07/2007 GLUCOSURE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90011E1 APEX BIOTECHNOLOGY CORP.
K090043 01/07/2009 AUTOSURE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90011F9 APEX BIOTECHNOLOGY CORP.
K073648 12/26/2007 GLUCOSURE STAR BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90000E1 APEX BIOTECHNOLOGY CORP.
K070088 01/09/2007 ASSURE 4 BLOOD GLUCOSE MONITORING SYSTEM APEX BIOTECHNOLOGY CORP.


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