Infopia Co, Ltd. - FDA 510(k) Cleared Devices
Recent clearances: BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose Monitoring System, GDH Professional Blood Glucose Monitoring System and GDH Professional LED Blood Glucose Monitoring System, HEMOCUE HBA1C 501 GLYCOSYLATED HEMOGLOBIN MONITORING SYSTEM
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