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509 FDA 510(k) clearances · Product code

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RecordFirmDate
BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose Monitoring System (K160365)Infopia Co, Ltd.2016-09-28
ACCU-CHEK Guide Blood Glucose Monitoring System (K160944)Roche Diabetes Care, Inc.2016-08-31
iHealth Align Gluco-Monitoring system (K153286)Andon Health Co, Ltd.2016-08-19
Wireless Smart Gluco-Monitoring System (K153278)Andon Health Co, Ltd.2016-08-19
On Call Pro Blood Glucose Monitoring System (K161867)Acon Laboratories2016-08-05
UniStrip1 Generic Blood Glucose Test Strips (K160038)Ok Biotech Co., Ltd.2016-07-29
PRODIGY ASTRO Blood Glucose Monitoring System, PRODIGY ASTRO PRO Blood Glucose Monitoring System (K152599)Ok Biotech Co., Ltd.2016-07-20
Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next Blood Glucose Monitoring System (K160430)Ascensia Diabetes Care U.S., Inc.2016-06-24
SD GlucoNavii Mentor BT Blood Glucose Monitoring System, SD GlucoNavii Mentor BT Multi Blood Glucose Monitoring System (K153201)Sd Biosensor2016-06-24
StatStrip Xpress Blood Glucose Monitoring System (K160156)Nova Biomedical Corporation2016-06-23
POGO Automatic Blood Glucose Monitoring System (K152493)Intuity Medical, Inc.2016-04-25
AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System (K152365)Agamatrix, Inc.2016-04-21
TRUE METRIX GO Self Monitoring Blood Glucose System (K143548)Trividia Health, Inc.2016-04-01
FreeStyle Precision Neo H Blood Glucose Monitoring System (K153330)Abbott Diabetes Care, Inc.2016-02-19
MyGlucoHealth Wireless System (K143169)Entra Health Systems2016-01-08
Dario Blood Glucose Monitoring System (K150817)Labstyle Innovations, Ltd.2015-12-21
PRODIGY iConnect Blood Glucose Monitoring System (K142785)Ok Biotech Co., Ltd.2015-12-17
Freestyle Freedom Blood Glucose Monitoring Sytem (K152442)Abbott Laboratories2015-12-17
OneTouch Ultra Plus Flex Blood Glucose Monitoring System (K151611)Lifescan Europe2015-12-14
iHealth Align Gluco-Monitoring System, iHealth BG5 wireless Smart Gluco-Monitoring System, iHealth BG5L wireless Smart Gluco-Monitoring System (K150833)Andon Health Co, Ltd.2015-12-04
Gmate Origin Blood Glucose Monitoring System (K151658)Philosys, Inc.2015-12-01
Contour Next USB Blood Glucose Monitoring System (K150942)Bayer Healthcare2015-11-25
SD GlucoNFC Blood Glucose Monitoring System, SD GlucoNFC Multi Blood Glucose Monitoring System (K151265)Sd Biosensor2015-11-24
Gmate SMART Blood Glucose Monitoring System (K150299)Philosys, Inc.2015-11-19
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 (K150396)Apex BioTechnology Corp.2015-10-14
Joinsoon EON L Glucose Monitoring System and Joinsoon EON LS Glucose Monitoring System (K140325)Joinsoon Medical Technology Co, Ltd.2015-10-13
GMATE MINI BLOOD GLUCOSE MONITORING SYSTEM, GMATE STEP BLOOD GLUCOSE MONITORING SYSTEM (K141656)Philosys, Inc.2015-10-02
FreeStyle Precision Neo Blood Glucose Monitoring System (K142928)Abbott Diabetes Care, Inc.2015-09-30
U-RIGHT TD-4116 Blood Glucose Monitoring System, U-RIGHT TD-4116 Pro Blood Glucose Monitoring System (K151100)Taidoc Technology Corporation2015-09-29
On Call Express Pro Blood Glucose Monitoring System (K151595)ACON Laboratories, Inc.2015-09-05
GDH Professional Blood Glucose Monitoring System and GDH Professional LED Blood Glucose Monitoring System (K150274)Infopia Co, Ltd.2015-08-26
Assure Prism multi Blood Glucose Monitoring System (K151164)I-Sens, Inc.2015-08-07
SD GLUCONAVII MENTOR NFC MULTI BLOOD GLUCOSE MONITORING SYSTEM, AND SD GLUCONAVII MENTOR NFC BLOOD GLUCOSE MONITORING SYSTEM (K132929)Sd Biosensor, Inc.2015-08-05
OneTouch Verio Flex Blood Glucose Monitoring System (K150214)Lifescan Europe2015-07-31
Rightest Blood Glucose Monitoring System GM700, Rightest Blood Glucose Monitoring System GM650, GE200 Blood Glucose Monitoring System, and GE300 Talking Blood Glucose Monitoring System (K141292)Bionime Coporation2015-06-09
FreeStyle Lite Blood Glucose Monitoring System (K150332)Abbott Laboratories2015-06-05
FreeStyle Freedom Lite Blood Glucose Monitoring System (K150531)Abbott Laboratories2015-06-05
GE333 Blood Glucose Monitoring System (K143387)Bionime Coporation2015-06-03
CARDIOCHEK PLUS TEST SYSTEM, CARDIOCHEK HOME TEST SYSTEM (K140068)Polymer Technology Systems, Inc.2015-05-22
SUPERCHECK PLUS BLOOD GLUCOSE MONITORING SYSTEM, SUPER CHECK PLUS MULTI BLOOD GLUCOSE MONITORING SYSTEM (K141351)Biotest Medical Corp.2015-05-19
Goodlife AC-300 Blood Glucose Monitoring System, Goodlife AC-301 Blood Glucose Monitoring System, Goodlife AC-302 Blood Glucose Monitoring System, Goodlife AC 303 Blood Glucose Monitoring System, Goodlife AC-304 Blood Glucose Monitoring System Goodlife AC-305 Blood Glucose Monitoring System, Goodlife AC-300 Professional Blood Glucose Monitoring System, Goodlife AC-301 Professional Blood Glucose Monitoring System Goodlife AC-30 (K140150)Hmd Biomedical, Inc.2015-05-14
FORA GD43 Blood Glucose Monitoring System (K143467)Taidoc Technology Corporation2015-05-07
BGM009 BLOOD GLUCOSE MONITORING SYSTEM (K141036)Apex BioTechnology Corp.2015-05-01
I-QARE DS-W BLOOD GLUCOSE MONITORING SYSTEM (K132663)Alliance International Co., Ltd.2015-04-20
PRODIGY AUTOCODE EJECT BLOOD GLUCOSE MONITORING SYSTEM (K141914)Ok Biotech Co., Ltd.2015-04-15
TRUE METRIX AIR Self-Monitoring Blood Glucose System, TRUE METRIX AIR PRO Professional Blood Gulcose Monitoring System (K150052)Nipro Diagnostics, Inc.2015-03-26
ACCU-CHEK AVIVA CONNECT BLOOD GLUCOSE MONITORING SYSTEM (K141867)Roche Diagnostics2015-03-03
HEALTH2SYNC MOBILE APPLICATION, HEALTH2SYNC SMART CABLE (K141862)H2, Inc.2014-12-02
FREESTYLE PRECISION NEO BLOOD GLUCOSE: MONITORING SYSTEM, TEST STRIPS (50CT), TEST STRIPS (100CT) (K140371)Abbott Diabetes Care, Inc.2014-09-30
GLUCOVITAAL H1A BLOOD GLUCOSE MONITORING SYSTEM (K141829)Ceragem Medisys, Inc.2014-09-24
FIA Blood Glucose Monitoring System (G2) (K131173)Hmd Biomedical, Inc.2014-09-18
GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, RELION MICRO BLOOD GLUCOSE MONITORING SYSTEM (K142035)Arkray Factory, Inc.2014-09-05
ACCU-CHEK Performa Blood Glucose Monitoring System (K133741)Roche Diagnostics2014-08-29
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM ( GM720, RIGHTEST PROFESSIONAL BGMS GM720 (K140210)Bionime Corporation2014-08-22
OKMETER DIRECT BLOOD GLUCOSE MONITORING SYSTEM (K132633)Ok Biotech Co., Ltd.2014-08-14
GMATE SMART BLOOD GLUCOSE MONITORING SYSTEM, GMATE SMART APPLICATION (K131230)Philosys, Inc.2014-08-04
TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRIX PRO PROFESSIONAL MONITORING BLOOD GLUCOSE SYSTEM (K140100)Nipro Diagnostics, Inc.2014-08-01
LABONACHECK GLUPPY BLOOD GLUCOSE MONITORING SYSTEM (K140141)Ceragem Medisys, Inc.2014-07-03
MEDISIGN BLOOD GLUCSE MONITORING SYSTEM, MEDISIGN MULTI BLOOD GLUCOSE MONITORING SYSTEM (K133260)Tianjin Empecs Medical Device Co., Ltd.2014-06-27
IDEAL LIFE GLUCO-MANAGER BLOOD GLUCOSE MONITORING SYSTEM (K132180)Ideal Life, Inc.2014-06-25
CONTOUR NEXT EZ BLOOD GLUCOSE METER (K130265)Bayer Healthcare, LLC2014-06-23
IHEALTH ALIGN MINI GLUCO-MONITORING SYSTEM (K133790)Andon Health Co, Ltd.2014-05-22
ACCU-CHEK AVIVA PLUS SYSTEM (K133862)Roche Diagnostics Corporation2014-04-29
ELEMENTV BLOOD GLUCOSE MONITORING SYSTEM (K132406)Infopia Co, Ltd.2014-04-18
RIGHTEST DIABETES MANAGEMENT SOFTWARE AND ADAPTER (EXISTING CLEARED K113007),RIGHTEST NEW ADAPTERS-3,GE DIABETES MANAGEM (K133522)Bionime Coporation2014-04-17
EM40 SELF-MONITORING BLOOD GLUCOSE SYSTEM (K133389)Eps Bio Technology Corp.2014-04-15
ELEMENT TM LITE BLOOD GLUCOSE MONITORING SYSTEM (K133045)Infopia Co, Ltd.2014-04-10
EMV3.1 PRO BLOOD GLUCOSE SYSTEM AND EMV3.1 SELF MONITORING BLOOD GLUCOSE SYSTEM (K133647)Eps Bio Technology Corp.2014-02-27
EASY PLUS II BLOOD GLUCOSE MONITORING SYSTEM,EASY PLUS II MULTI BLOOD GLUCOSE MONITORING SYSTEM,SMARTEST PERSONA II BLOO (K133509)Biotest Medical Corp.2014-02-21
GLUCOMENTOR BLOOD GLUCOSE MONITORING SYSTEM, GLUCOMENTOR MULTI BLOOD GLUCOSE MONITORING SYSTEM (K123517)Sd Biosensor2014-01-17
ACON ON CALL DIABETES MANAGEMENT SOFTWARE (K131469)ACON Laboratories, Inc.2014-01-06
FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM (K132511)Abbott Diabetes Care, Inc.2013-12-24
ON CALL SHARP BLOOD GLUCOSE MONITORING SYSTEM (K130284)ACON Laboratories, Inc.2013-12-20
ON CALL EXPRESS BLOOD GLUCOSE MONITORING SYSTEM (K132086)ACON Laboratories, Inc.2013-12-19
SMARTLOG DIABETES MANAGEMENT SOFTWARE (K133346)I-Sens, Inc.2013-12-19
HEALTHPRO PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM (K132862)Infopia Co, Ltd.2013-12-12
GLUNEO LITE GLUCOSE MONITORING SYSTEM, GLUNEO LITE PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM (K132966)Infopia Co, Ltd.2013-12-05
PRODIGY CHOICE (K122340)Prodigy Diabetes Care, LLC2013-11-26
GLB BENECHECK PREMIUM GLU MONITORING SYSTEM (K123090)General Life Biotechnology Co., Ltd.2013-11-22
CARESENS N VOICE MULTI BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N VOICE MULTI BLOOD GLUCOSE METER (K132288)I-Sens, Inc.2013-11-22
AGAMATRIX HEALTH MANAGER (K132821)Agamatrix, Inc.2013-11-20
UNISTRIP 1 (K113135)Unistrip Technologies, LLC2013-11-06
PREFERRED BLOOD GLUCOSE MONITORING SYSTEM (K122338)Prodigy Diabetes Care, LLC2013-11-05
DA01 BLOOD GLUCOSE MONITORING SYSTEM (K132338)Delbio Incorporation2013-10-24
GLOOKO DEVICE SYSTEM FOR GLOOKO APPLICATION (K132272)Glooko, Inc.2013-10-17
FOCUS BLOOD GLUCOSE MONITORING SYSTEM, FOCUS PRO BLOOD GLUCOSE MONITORING SYSTEM (K131013)Nova Biomedical Corporation2013-10-17
CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE MONITOR (K122370)Bayer Healthcare2013-09-26
ONETOUCH VERIO BLOOD GLUCOSE MONITORING SYSTEM (K131363)Cilag GmbH International2013-08-30
DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM (K130244)Delbio Incorporation2013-08-23
CARESENS N LINK BLOOD GLUCOSE MONITORING SYSTEM; CARESENS N LINK MULTI BLOOD BLUCOSE MONITORING SYSTEM (K130696)I-Sens, Inc.2013-08-21
TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRI PRO PROFESSIONAL MONITORING BLOOD GLUCOSE SYSTEM (K132072)Nipro Diagnostics, Inc.2013-08-15
EBCHEK BLOOD GLUCOSE MONITORING SYSTEM (K122181)Visgeneer, Inc.2013-08-15
ACURA PLUS MULTI BLOOD GLUCOSE MONITORING SYSTEM (K131419)I-Sens, Inc.2013-08-09
ACCU-CHEK AVIVA PLUS TEST STRIP (K131029)Roche Diagnostics Operations, Inc.2013-08-09
GLUNEO BLOOD GLUCOSE MONITORING SYSTEM, AND PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM (K130181)Infopia Co, Ltd.2013-07-31
BROADMASTER HEALTHCARE SYSTEM (K130621)Broadmaster Biotech Corporation2013-07-30
LINKDR 2.0 DIABETES MANAGEMENT SOFTWARE (K130657)All Medicus Co., Ltd.2013-07-15
SOLUSMOBILE BLOOD GLUCOSE MANAGMENT SYSTEM (K123559)Biotest Medical Corp.2013-06-28
FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM (K130094)Abbott Diabetes Care2013-06-27
LIPIDPRO LIPID PROFILE AND GLUCOSE MEASURING SYSTEM, LIPIDPRO PROFESSIONAL LIPID PROFILE AND GLUCOSE MEASURING SYSTEM. (K130295)Infopia Co, Ltd.2013-06-21
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