Medical Device Manufacturer · KR , Anyang Kvunggi

Infopia Co, Ltd. - FDA 510(k) Cleared Devices

20 submissions · 20 cleared · Since 2005
20
Total
20
Cleared
0
Denied

Infopia Co, Ltd. has 20 FDA 510(k) cleared chemistry devices. Based in Anyang Kvunggi, KR.

Historical record: 20 cleared submissions from 2005 to 2016.

Browse the complete list of FDA 510(k) cleared chemistry devices from this manufacturer. Filter by specialty or product code using the sidebar.

FDA 510(k) Regulatory Record - Infopia Co, Ltd.

20 devices
1-20 of 20
Cleared Sep 28, 2016
BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood...
K160365 · NBW
Chemistry · 232d
Cleared Aug 26, 2015
GDH Professional Blood Glucose Monitoring System and GDH Professional LED...
K150274 · NBW
Chemistry · 203d
Cleared Jul 24, 2014
HEMOCUE HBA1C 501 GLYCOSYLATED HEMOGLOBIN MONITORING SYSTEM
K141750 · LCP
Chemistry · 24d
Cleared Apr 18, 2014
ELEMENTV BLOOD GLUCOSE MONITORING SYSTEM
K132406 · NBW
Chemistry · 259d
Cleared Apr 10, 2014
ELEMENT TM LITE BLOOD GLUCOSE MONITORING SYSTEM
K133045 · NBW
Chemistry · 195d
Cleared Dec 12, 2013
HEALTHPRO PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM
K132862 · NBW
Chemistry · 91d
Cleared Dec 05, 2013
GLUNEO LITE GLUCOSE MONITORING SYSTEM, GLUNEO LITE PROFESSIONAL BLOOD GLUCOSE...
K132966 · NBW
Chemistry · 76d
Cleared Jul 31, 2013
GLUNEO BLOOD GLUCOSE MONITORING SYSTEM, AND PROFESSIONAL BLOOD GLUCOSE...
K130181 · NBW
Chemistry · 187d
Cleared Jun 21, 2013
LIPIDPRO LIPID PROFILE AND GLUCOSE MEASURING SYSTEM, LIPIDPRO PROFESSIONAL...
K130295 · NBW
Chemistry · 135d
Cleared Sep 07, 2012
HEMOCUE HBA1C 501
K121366 · LCP
Chemistry · 123d
Cleared Jul 13, 2012
HEALTHPRO BLOOD GLUCOSE MONITORING SYSTEM
K113192 · NBW
Chemistry · 256d
Cleared May 08, 2012
ELEMENT BLOOD GLUCOSE MONITORING SYSTEM
K113670 · CGA
Chemistry · 147d
Cleared Nov 04, 2011
ELEMENT PLUS BLOOD GLUCOSE MONITORING SYSTEM
K103021 · NBW
Chemistry · 388d
Cleared May 27, 2010
GLUCOPHONE BLOOD GLUCOSE TEST SYSTEM, MODEL IGM-0025
K091168 · NBW
Chemistry · 400d
Cleared Jan 14, 2010
CLOVER A1C/GLYCOSYLATED HEMOGLOBIN MONITOR & BLOOD GLUCOSE MONITOR, MODEL...
K082275 · LCP
Chemistry · 521d
Cleared Dec 01, 2009
LIPIDPRO SYSTEM
K090405 · NBW
Chemistry · 285d
Cleared Nov 17, 2009
GLUCO LAB AUTO CODING, MODEL IGM-0022
K091157 · NBW
Chemistry · 210d
Cleared Oct 02, 2009
EOCENE SYSTEM
K090712 · NBW
Chemistry · 198d
Cleared Dec 24, 2008
ENVISION BLOOD GLUCOSE TEST SYSTEM
K082020 · NBW
Chemistry · 161d
Cleared Aug 02, 2005
GLUCOLAB BLOOD GLUCOSE MONITORING SYSTEM
K051285 · CGA
Chemistry · 77d
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