Infopia Co, Ltd. - FDA 510(k) Cleared Devices
20
Total
20
Cleared
0
Denied
FDA 510(k) Regulatory Record - Infopia Co, Ltd. Chemistry ✕
20 devices
Cleared
Sep 28, 2016
BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood...
Chemistry
232d
Cleared
Aug 26, 2015
GDH Professional Blood Glucose Monitoring System and GDH Professional LED...
Chemistry
203d
Cleared
Jul 24, 2014
HEMOCUE HBA1C 501 GLYCOSYLATED HEMOGLOBIN MONITORING SYSTEM
Chemistry
24d
Cleared
Apr 18, 2014
ELEMENTV BLOOD GLUCOSE MONITORING SYSTEM
Chemistry
259d
Cleared
Apr 10, 2014
ELEMENT TM LITE BLOOD GLUCOSE MONITORING SYSTEM
Chemistry
195d
Cleared
Dec 12, 2013
HEALTHPRO PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM
Chemistry
91d
Cleared
Dec 05, 2013
GLUNEO LITE GLUCOSE MONITORING SYSTEM, GLUNEO LITE PROFESSIONAL BLOOD GLUCOSE...
Chemistry
76d
Cleared
Jul 31, 2013
GLUNEO BLOOD GLUCOSE MONITORING SYSTEM, AND PROFESSIONAL BLOOD GLUCOSE...
Chemistry
187d
Cleared
Jun 21, 2013
LIPIDPRO LIPID PROFILE AND GLUCOSE MEASURING SYSTEM, LIPIDPRO PROFESSIONAL...
Chemistry
135d
Cleared
Sep 07, 2012
HEMOCUE HBA1C 501
Chemistry
123d
Cleared
Jul 13, 2012
HEALTHPRO BLOOD GLUCOSE MONITORING SYSTEM
Chemistry
256d
Cleared
May 08, 2012
ELEMENT BLOOD GLUCOSE MONITORING SYSTEM
Chemistry
147d
Cleared
Nov 04, 2011
ELEMENT PLUS BLOOD GLUCOSE MONITORING SYSTEM
Chemistry
388d
Cleared
May 27, 2010
GLUCOPHONE BLOOD GLUCOSE TEST SYSTEM, MODEL IGM-0025
Chemistry
400d
Cleared
Jan 14, 2010
CLOVER A1C/GLYCOSYLATED HEMOGLOBIN MONITOR & BLOOD GLUCOSE MONITOR, MODEL...
Chemistry
521d
Cleared
Dec 01, 2009
LIPIDPRO SYSTEM
Chemistry
285d
Cleared
Nov 17, 2009
GLUCO LAB AUTO CODING, MODEL IGM-0022
Chemistry
210d
Cleared
Oct 02, 2009
EOCENE SYSTEM
Chemistry
198d
Cleared
Dec 24, 2008
ENVISION BLOOD GLUCOSE TEST SYSTEM
Chemistry
161d
Cleared
Aug 02, 2005
GLUCOLAB BLOOD GLUCOSE MONITORING SYSTEM
Chemistry
77d