FDA 510(k) Applications Submitted by Hsue-Mei Lee
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K170267 |
01/27/2017 |
BGM009 Plus Blood Glucose Monitoring System |
Apex Bio Technology 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. |
| K143750 |
12/31/2014 |
MEG-2B Blood Glucose Monitoring System, MEG-2B Pro Blood Glucose Monitoring System |
APEX BIO TECHNOLOGY CORP |
|
|
