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509 FDA 510(k) clearances · Product code

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RecordFirmDate
BASESENS BLOOD GLUCOSE MONITORING SYSTEM (K093475)Hygeia, Inc.2010-02-24
EASYMAX V SELF MONITORING BLOOD GLUCOSE SYSTEM (K092894)Eps Bio Technology Corp.2010-02-24
INTOUCH DIABETES (K093789)Symcare Personalized Health Solutions, Inc.2010-02-19
FORA G71A BLOOD GLUCOSE MONITORING SYSTEM, TD-4274 BLOOD GLUCOSE MONITORING SYSTEM (K093712)Taidoc Technology Corporation2010-02-19
MODELS FORA V30 AND TD-4242 BLOOD GLUCOSE MONITORING SYSTEMS (K093635)Taidoc Technology Corporation2010-02-18
FORA G72 BLODO GLUCOSE MONITORING SYSTEM/TD-4264 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4264 (K093005)Taidoc Technology Corporation2010-02-05
OKMETER MATCH BLOOD GLUCOSE MONITORING SYSTEM (K090609)Ok Biotech Co., Ltd.2010-02-04
EBCARRYON BLOOD GLUCOSE MONITORING SYSTEM (K091765)Visgeneer, Inc.2010-01-19
NOVA MAX PLUS BLOOD GLUCOSE AND B-KETONE MONITOR SYSTEM, NOVA MAX PLUS B-KETONE CONTROL SOLUTIONS, NOVA MAX BLOOD GLUCOS (K091547)Nova Biomedical Corp.2010-01-15
FORA V10 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4244 (K093035)Taidoc Technology Corporation2009-12-24
NO-CODING BLOOD GLUCOSE MONITORING SYSTEM, MODELS TD-4251, TD-4252, TD-4253 AND TD-4254 (K092099)Taidoc Technology Corporation2009-12-10
SD CHECK GOLD (K082683)Standard Diagnostics, Inc.2009-12-08
DIDGET BLOOD GLUCOSE METER, MODEL 6181; CONTOUR BLOOD GLUCOSE TEST STRIPS, MODEL 7080 (K090628)Bayer Healthcare, LLC2009-12-04
LIPIDPRO SYSTEM (K090405)Infopia Co, Ltd.2009-12-01
MICRODOT XTRA (K083273)Cambridge Sensors Limited2009-11-19
GLUCO LAB AUTO CODING, MODEL IGM-0022 (K091157)Infopia Co, Ltd.2009-11-17
SUPERCHECK 1 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 6268 (K091815)Biotest Medical Corp.2009-11-16
EASYPLUS MINI MASTERDRIVER SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL EPS09009 (K092887)Eps Bio Technology Corp.2009-10-21
POCKETCHEM EZ BLOOD GLUCOSE MONITORING SYSTEM (K090653)Arkray Factory USA, Inc.2009-10-09
EOCENE SYSTEM (K090712)Infopia Co, Ltd.2009-10-02
BLOOD GLUCOSE MONITORING SYSTEM, MODEL FORA G90/TD-4234 (K091898)Taidoc Technology Corporation2009-09-18
CONTOUR USB BLOOD GLUCOSE METER, GLUCOSE TEST STRIPS; GLUCOFACTS DELUX DIABETES MANAGEMENT SYSTEM (K091820)Bayer Healthcare2009-08-26
EASYPLUS MINI R13N SELF MONITORING BLOOD GLUCOSE SYSTEM (K091481)Eps Bio Technology Corp.2009-08-18
ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 46001 (K090332)Arkray Factory USA, Inc.2009-08-14
GLUCOMANAGER DATA MANAGEMENT SOFTWARE (K091229)Eps Bio Technology Corp.2009-07-31
POLYTEL GMA, MODELS PWR-08-67, PWR-08-07, PWR-08-09 (K091296)Polymap Wireless2009-07-17
AP-1000 BLOOD GLUCOSE MONITORING SYSTEM (K090389)Bestgen Biotech Corp.2009-07-14
U-RIGHT TD-4227 NO CODING BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4222 (K090188)Taidoc Technology Corporation2009-07-13
FORE V10 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4244, FOREA V12 BLODO GLUCOSE MONITORING SYSTEM, MODEL TD-4247 (K090404)Taidoc Technology Corporation2009-06-23
EASY STEP AND DIACHEX+ PRO BLOOD GLUCOSE MONITORING SYSTEMS (K090629)Tyson Bioresearch, Inc.2009-06-04
FORA G30 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4241 (K090187)Taidoc Technology Corporation2009-05-12
GLUCODR AUTO SYSTEM (K083628)All Medicus Co., Ltd.2009-05-01
CLEVER CHEK BLOOD GLUCOSE MONITORING SYSTEM; ACHTUNG BLOOD GLUCOSE MONITORING SYSTEM (K090185)Taidoc Technology Corporation2009-04-24
ON-CALL PLUS BLOOD GLUCOSE MONITORING SYSTEM (K090057)Acon Laboratories Co.2009-04-08
TRUEBALANCE BLOOD GLUCOSE SYSTEM (K090495)Home Diagnostics, Inc.2009-03-27
FORA V12 NO-CODING BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4247 (K090536)Taidoc Technology Corporation2009-03-26
BETACHEK GLUCOSE TEST (K062187)National Diagnostic Products2009-03-24
SYMCARE DIABETES MANAGEMENT PROGRAM (K083263)Symcare Personalized Health Solutions, Inc.2009-03-13
GLUCODR PLUS SYSTEM, MODEL AGM-3000 (K082328)All Medicus Co., Ltd.2009-02-27
G5 INFINITY BLODO GLUCOSE MONITORING SYSTEM WITH MODEL IGM, 0024A (K082201)U. S. Diagnostics, Inc.2009-02-20
DUO-CARE BLOOD GLUCOSE AND BLOOD PRESSURE MONITOR SYSTEM (K080853)Genexel-Sein, Inc.2009-02-20
CARESENS N BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N METER, MODEL GM5051A OR GM5051B OR GM5051C (COLOR) (K083468)I-Sens, Inc.2009-02-10
JAZZ WIRELESS BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-03381 (K083265)Agamatrix, Inc.2009-02-03
EASYPLUS MINI R2N SELF MONITORING GLUCOSE TEST SYSTEM (K081796)Eps Bio Technology Corp.2009-01-23
EASYMAX N SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL: EPS08008 (K083099)Eps Bio Technology Corp.2009-01-16
EASY2CHECK BLOOD GLUCOSE AND BLOOD PRESSURE MONITORING SYSTEM (K082521)Card Guard Scientific Survival , Ltd.2009-01-16
MYGLUCOHEALTH GLUCOSE MONITORING SYSTEMS (K081703)Entra Health Systems, Ltd.2009-01-08
ENVISION BLOOD GLUCOSE TEST SYSTEM (K082020)Infopia Co, Ltd.2008-12-24
FORA TD-4244 & TD-4245 BLOOD GLUCOSE MONITORING SYSTESM (K081715)Taidoc Technology Corporation2008-12-17
PRO GLUCOSE TEST STRIP (K082169)Taidoc Technology Corporation2008-12-04
RELION ULTIMA ADVANCE BLOOD GLUCOSE MONITORING SYSTEM MODELS, BGMS 71030-01 STRIPS: 7103-01 (20 COUNT) (K081975)Abbott Diabetes Care, Inc.2008-11-26
ONETOUCH VITA BLOOD GLUCOSE MONITORING SYSTEM (K082513)Lifescan, Inc.2008-10-22
CARESENS BLOOD GLUCOSE MONITORING SYSTEM; CARESENS II METER, MODEL GM505C; CARESENS POP METER, MODEL GM505EA OR GM505EB (K080923)I-Sens, Inc.2008-10-17
GLUCOFACTS EXPRESS DIABETES MANAGEMENT SOFTWARE (K082486)Bayer Healthcare, LLC2008-10-08
ULTRA TRAK PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-455 (K082618)Taidoc Technology Corporation2008-10-07
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM100 (K081451)Bionime Corporation2008-09-18
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM110 (K081450)Bionime Corporation2008-09-11
PRECISION XCEED PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM WITH MODELS BGMS:70900-03, 70090-02, G3CH STRIPS (K080960)Abbott Diabetes Care, Inc.2008-09-05
TYSONBIO LINK HEALTH MANAGEMENT SYSTEM (K081726)Tyson Bioresearch, Inc.2008-08-26
TRUERESULT BLOOD GLUCOSE SYSTEM E4H01-81 (K080641)Home Diagnostics, Inc.2008-08-19
TRUE2GO BLOOD GLUCOSE SYSTEM, MODEL F4H01-81 (K080710)Home Diagnostics, Inc.2008-08-13
U-RIGHT TD-4247 BLOOD GLUCOSE MONITORING SYSTEM (K081957)Taidoc Technology Corporation2008-08-05
AG-605 BLOOD GLUCOSE MONITORING SYSTEM (K073030)Andon Health Co, Ltd.2008-07-21
ACCU-CHEK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM (K081389)Roche Diagnostics2008-07-15
IDEAL LIFE POD (MODEL ILP 0001) (K080538)Ideal Life, Inc.2008-07-03
DIACHEX BASIC BLOOD GLUCOSE MONITORING SYSTEM, DIACHEX SUPERB BLOOD GLUCOSE MONITORING SYSTEM (K072854)Tyson Bioresearch, Inc.2008-06-30
IDEAL LIFE GLUCO-MANAGER GMM 0001 BLOOD GLUCOSE MONITORING SYSTEM (K080283)Taidoc Technology Corporation2008-06-27
CLEVER CHEK AUTO-CODE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4243 (K081144)Taidoc Technology Corporation2008-06-23
ONETOUCH ZOOM DIABETES MANAGEMENT PROGRAM (K081318)Lifescan, Inc.2008-06-09
CLEVER CHEK TD-3250C BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM (K080014)Taidoc Technology Corporation2008-06-09
SURECHEK EDGE BLOOD GLUCOSE MONITORING SYSTEM, MODEL SMS-4240 (K080501)Taidoc Technology Corporation2008-04-21
ONETOUCH ULTRALINK BLOOD GLUCOSE MONITORING SYSTEM (K073231)Lifescan, Inc.2008-04-18
3TEST SUPREME GLUCOSE MONITORING SYSTEM (K072905)Neuero Engineering, Inc.2008-04-18
DIACHEX+DETERMINE BLOOD GLUCOSE MONITORING SYSTEM, DIACHEX-INFINITY BLOOD GLUCOSE MONITORING SYSTEM (K073492)Tyson Bioresearch, Inc.2008-04-08
CLEVER CHEK BLOOD GLUCOSE MONITORING SYSTEM, MODELS TD-4209, -4222, -4225 AND -4226 AND ACHTUNG BLOOD GLUCOSE MONITORING (K073494)Taidoc Technology Corporation2008-04-02
GLUCOSURE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90011E1 (K073137)Apex BioTechnology Corp.2008-04-01
MCT-DIABETES (K073699)Mycare Team, Inc.2008-03-26
EZ SCAN PLUS BLOOD GLUCOSE MONITORING SYSTEM (K072441)Tyson Bioresearch, Inc.2008-03-25
EVOLUTION BLOOD GLUCOSE MONITORING SYSTEM (K072369)Hmd Biomedical, LLC2008-03-21
PRODIGY VOICE BLOOD GLUCOSE MONITORING SYSTEM (K073118)Diagnostic Devices, Inc.2008-03-05
CLEVER CHEK MODEL TD-4232 BLOOD GLUCOSE MONITORING SYSTEM (K073119)Taidoc Technology Corporation2008-03-03
MAJOR III BLOOD GLUCOSE MONITORING SYSTEM (K072274)Bestgen Biotech Corp.2008-02-29
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM310 (K072054)Bionime Corporation2008-02-28
WAVESENSE KEYNOTE CODELESS BLOOD GLUCOSE MONITORING SYSTEM (K073573)Agamatrix2008-01-30
PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4227, CLEVER CHEK TD-4227 BLOOD GLUCOSE MONITORING SYSTEM (K072784)Taidoc Technology Corporation2007-12-21
EASYPLUS MINI SELF MONITORING GLUCOSE TEST SYSTEM, MODELS R1 AND R2 (K070053)Eps Bio Technology Corp.2007-12-03
CLEVER CHEK TD-4209 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4209, TD-4222, TD-4225 (K071493)Taidoc Technology Corporation2007-10-26
ONETOUCH SELECT BLOOD GLUCOSE MONITORING SYSTEM (K072543)Lifescan, Inc.2007-10-05
ADVOCATE REDI-CODE BLOOD GLUCOSE MONITORING SYSTEM, MODELS TD-4223E; TD-4223F (K072039)Taidoc Technology Corporation2007-10-03
MODIFICATION TO: JAZZ BLOOD GLUCOSE MONITORING SYSTEM (K072413)Agamatrix2007-09-27
REVOLUTION TD-4229 BLOOD GLUCOSE MONITORING SYSTEM (K072489)Taidoc Technology Corporation2007-09-20
PTS PANELS CHOL+HDL+GLU PANEL TEST STRIPS (K071507)Polymer Technology Systems, Inc.2007-09-10
GLUCOCARD X-METER BLOOD GLUCOSE MONITORING SYSTEM (K063771)Arkray Factory USA, Inc.2007-08-09
JAZZ BLOOD GLUCOSE MONITORING SYSTEM (K071393)Agamatrix2007-07-20
MEDAPPS REMOTE PATIENT MONITORING, MODEL MA 100 (K062377)Medapps, Inc.2007-07-03
POLYMAP PWR-08-03 (K070559)Polymap Wireless2007-06-29
MICRODOT BLOOD GLUCOSE MONITORING SYSTEM (K070524)Cambridge Sensors Limited2007-06-22
CLEVER CHEK HEALTH CARE SYSTEM SOFTWARE, VERSION 1.0 (K070941)Taidoc Technology Corporation2007-06-21
NOVA MAX BLOOD GLUCOSE MONITOR SYSTEM, 90001,90002 (K070255)Nova Biomedical Corp.2007-06-13
ACCU-CHEK PERFORMA SYSTEM (K070585)Roche Diagnostics Corp.2007-05-25
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