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509 FDA 510(k) clearances · Product code

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RecordFirmDate
VERI-Q MGD-1001 BLOOD GLUCOSE MONITORING SYSTEM, VERI-Q PLUS MGD-1001 BLOOD GLUCOSE MONITORING SYSTEM (K123007)Mico Biomed Co., Ltd.2013-06-19
VERI-Q SELF-TESTING AND VERI-Q PLUS MGD-2001 BLOOD GLUCOSE MONITORING SYSTEMS (K123016)Mico Biomed Co., Ltd.2013-06-18
TYSONBIO AC500, AC800 BLOOD GLUCOSE MONITORING SYSTEM, TYSONBIO AC500 AC800 PRO BLOOD GLUCOSE MONITORING SYSTEM (K123087)Tyson Bioresearch, Inc.2013-06-18
FORACARE GD20 BLOOD GLUCOSE MONITORING SYSTEM (K124040)Taidoc Technology Corporation2013-05-16
SMARTEST GLUCOWISE BLOOD GLUCOSE MONITORING SYSTEM, AND SMARTEST GLUCOSWISE MULTI BLOOD GLUCOSE MONITORING SYSTEM (K122525)Biotest Medical Corp.2013-05-02
GLOOKO DEVICE SYSTEM FOR GLOOKO LOGBOOK+ APPLICATION (K130886)Glooko, Inc.2013-04-25
TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRIX PROFESSIONAL MONITORING BLOOD GLUCOSE SYSTEM (K120989)Nipro Diagnostics, Inc.2013-04-24
IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER APPLICATION (K130535)Agamatrix, Inc.2013-04-17
IHEALTH BG5/BG5L WIRELESS SMART GLUCOSE MONITORING SYSTEM (K123935)Andon Medical Co., Ltd.2013-04-12
DIAVUE PRUDENTIAL BLOOD GLUCOSE MONITORING SYSTEM (K122307)Biocare Corporation2013-04-05
FREESTYLE AUTO-ASSIST SOFTWARE VERSON 2.0 WITH MODEL PRT24238-001 (K123089)Abbott Laboratories2013-04-05
SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEM (K130138)Roche Diagnostics Corp.2013-03-15
GENESIS HEALTH RECORD SYSTEM, (GHRS) (K123136)Genesis Health Technologies2013-03-07
ACCU-CHECK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM (K113614)Roche Diagnostics2013-02-12
LABONACHECK GLUPPY BLOOD GLUCOSE MONITORING SYSTEM (K102751)Ceragem Medisys, Inc.2013-02-11
ONETOUCH REVEAL DIABETES MANAGEMENT APPLICATION (K120558)Lifescan, Inc.2013-02-07
ONETOUCH VERIO SYNC BLOOD GLUCOSE MONITORING SYSTEM (K120708)Cilag GmbH International2013-02-07
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM GM700 GE GE200 BLOOD GLUCOSE MONITORING SYSTEM RIGHTEST BLOOD GLUCOSE MONITORIN (K123008)Bionime Corporation2013-01-25
GLOOKO LOGBOOK CHARTS (K122142)Glooko, Inc.2012-12-21
ON CALL VIVID BLOOD GLUCOSE MONITORING SYSTEM (K123010)ACON Laboratories, Inc.2012-12-14
DA01 BLOOD GLUCOSE MONITORING SYSTEM (K120866)Delbio Incorporation2012-12-11
BLOOD GLUCOSE MONITORING SYSTEM (K120813)Andon Medical Co., Ltd.2012-12-07
GENSTRIP TEST STRIP MODEL 100-201 (K103542)Shasta Technologies, LLC2012-11-30
ACCU-CHEK INFORM II BLOOD GLUCOSE MONITORING SYSTEM (K121679)Roche Diagnostics2012-10-11
TEST, BLOOD GLUCOSE SYSTEM (K120064)Hmd Biomedical, Inc.2012-09-05
TYSONBIO MD100 BLOOD GLUCSE MONITORING ,TYSONBIO MD100 PRO BLOOD GLUCISE MONITORING SYSTEM (K112916)Tyson Bioresearch, Inc.2012-08-21
BIOLAND G-423 GLOOD GLUCOSE MONITORING SYSTEM (K113077)Taidoc Technology Corporation2012-08-03
BIONIME RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM650 (K120423)Bionime Corporation2012-08-03
HEALTHPRO BLOOD GLUCOSE MONITORING SYSTEM (K113192)Infopia Co, Ltd.2012-07-13
CARESENS N VOICE BLOOD GLUCOSE MONITORING SYSTEM (K121133)I-Sens, Inc.2012-07-10
AUTOSURE VOICE 3 PLUS BLOOD GLUCOSE MONITORING SYSTEM (K120649)Apex BioTechnology Corp.2012-07-06
CONTOUR NEXT USB BLOOD GLUCOSE MONITORING SYSTEM (K121087)Bayer Healthcare2012-06-28
HL 568 SELF MONITORING BLOOD GLUCOSE SYSTEM, HL 568BA SELF-MONIROTING BLOOD GLUCOSE SYSTEM (K110074)Health & Life Co., Ltd.2012-05-25
ADVOCATE REDI-CODE+BMB-EA001S BLOOD GLUCOSE MONITORING SYSTEM (K120183)Broadmaster Biotech Corperation2012-05-11
CARESENS N POP BLOOD GLUCOSE MONITORING SYSTEM CARESENS N POP BLOOD GLUCOSE METER CARESENS N BLOOD GLUCOSE TEST STRIP CA (K120351)I-Sens, Inc.2012-05-03
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM GM700 (K110737)Bionime Corporation2012-03-29
FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEM (K120568)Abbott Diabetes Care, Inc.2012-03-29
DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM; DIATRUE PLUS BLOOD GLUCOSE TEST STRIP; DIATRUE GLUCOSE CONTROL SOLUTION (K103329)Delbio Incorporation2012-03-13
NOVA MAX ONE BLOOD GLUCOSE MONITOR, NOVA MAX ONE BLOOD GLUCOSE TEST STRIPS (K112638)Nova Biomedical Corporation2012-03-09
MEDISIGN BLOOD GLUCOSE MONITORING SYSTEM (K111456)Tianjin Empecs Medical Device Co., Ltd.2012-02-28
AP-1010 AND AP-1020 BLOOD GLUCOSE MONITORING SYSTEM, MAJOR GLUCOSE CONTROL SOLUTION (K103044)Bestgen Biotech Corp.2012-02-10
DIACHECK SMART/SUPERIOR BLOOD GLUCOSE MONITORING SYSTEM (K113343)Delbio Incorporation2012-02-08
FORA DIAMOND PRIMA BLOOD GLUCOSE MONITORING SYSTEM, FORA DIAMOND MINI BLOOD GLUCOSE MONITORING SYSTEM (K111890)Taidoc Technology Corporation2012-02-06
MICRODOT & MICRODOT XTRA (K102383)Cambridge Sensors Limited2012-01-27
AG-608N BLOOD GLUCOSE MONITORING SYSTEM (K110017)Andon Medical Co., Ltd.2012-01-18
AUTOSURE VOICE II PLUS, AUTOSURE PLUS BLOOD GLUCOSE TEST STRIPS,CONTREX PLUS III (K113098)Apex BioTechnology Corp.2012-01-17
AP-1000 BLOOD GLUCOSE MONITORING SYSTEM, MODEL AP-1000, MAJOR GLUCOSE CONTROL SOLUTION (K100437)Bestgen Biotech Corp.2012-01-12
GLUCOSE TEST SYSTEM (K113137)Roche Diagnostics2012-01-06
FORA D40 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM (K101926)Taidoc Technology Corporation2011-12-20
FORA PREMIUM V10 BLOOD GLUCOSE MONITORING SYSTEM (K112275)Taidoc Technology Corporation2011-12-15
IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER APPLICATION, REV D (K103544)Agamatrix, Inc.2011-12-07
TD-4257 BLOOD GLUCOSE MONITORING SYSTEMS,TD 4257 MULTI BLOOD GLUCOSE MONITORING SYSTEMS (K112963)Taidoc Technology Corporation2011-11-22
IGLUCOSE SYSTEM (K111932)Positiveid Corporation2011-11-10
SWEETSPOT DIABETES DATA MANAGEMENT SERVICE (K111509)Sweetspot Diabetes Care, Inc.2011-11-09
ELEMENT PLUS BLOOD GLUCOSE MONITORING SYSTEM (K103021)Infopia Co, Ltd.2011-11-04
PRODIGY DIABETES MANAGEMENT SOFTWARE (K103115)Prodigy Diabetes Care, LLC2011-10-12
HEALTH-E-CONNECT SYSTEM (K102063)Alr Technologies2011-10-11
ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE (K112738)Andon Medical Co., Ltd.2011-09-30
COOL BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE METER, COOL CONTROL SOLUTION (K103396)I-Sens, Inc.2011-09-27
EASYGLUCO PLUS BLOOD GLUCOSE MONITORING SYSTEM (K110435)U. S. Diagnostics, Inc.2011-09-21
DIACHECK BLOOD GLUCOSE MONITORING SYSTEM MODEL: PREMIUM (K100806)Delbio Incorporation2011-09-16
GAL-1C BLOOD GLUCOSE MONITORING SYSTEM, GAL-1C TEST STRIPS (K102816)Apex BioTechnology Corp.2011-09-15
FORA GD20 BLOOD GLUCOSE MONITORING SYSTEM, U-RUGHT TD-4252D BLOOD GLUCOSE MONITORING SYSTEM (K101631)Taidoc Technology Corporation2011-09-02
TD-4239 BLOOD GLUCOSE MONITORING SYSTEM AND TD-4239 MULTI BLOOD GLUCOSE MONITORING SYSTEM (K101635)Taidoc Technology Corporation2011-08-31
TYSONBIO BLOOD GLUCOSE MONITORING SYSTEM, MODELS AC100 AND AC200 (K101543)Tyson Bioresearch, Inc.2011-08-30
ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE, AG-608 SINGLE & AG-608 MULTI BLOOD GLUCOSE MONITORING SYSTEMS (K102678)Andon Medical Co., Ltd.2011-08-26
BLOOD GLUCOSE MONITORING SYSTEM, MODELS AG-6081 AND AG-6951 (K101307)Andon Medical Co., Ltd.2011-08-09
TELCARE BLOOD GLUCOSE MONITORING SYSTEM, TEST STRIPS, CONTROL SOLUTIONS, TELSERVE-HOME USE, TELSERVE-PROFESSIONAL USE (K110571)Telcare, Inc.2011-07-28
AG-695 SINGLE AND MULTI BLOOD GLUCOSE MONITORING SYSTEM/AG-696 SINGLE AND MULTI BLOOD GLUCOSE MONITORING SYSTEM (K093755)Andon Medical Co., Ltd.2011-07-15
FORA POCT MANAGMENT SYSTEM (K111029)Taidoc Technology Corporation2011-07-01
U-RIGHT TD-4279 BLOOD GLUCOSE MONITORING SYSTEM, FORA GD40/TD-4272 BLOOD GLUCOSE MONITORING SYSTEM (K101509)Taidoc Technology Corporation2011-06-27
EASYMAX T1 SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL EPS10042 (K102345)Eps Bio Technology Corp.2011-06-21
CLEVER CHOICE VOICE+ BLOOD GLUCOSE MONITORING SYSTEM (K102049)Taidoc Technology Corporation2011-05-27
ARK CARE DIABETES MANAGMENT SYSTEM (K110709)Arkray Factory USA, Inc.2011-05-19
HEALTH CARE SYSTEM SOFTWARE (K110948)Taidoc Technology Corporation2011-05-13
AUTOSURE VOICE 3 BLOOD GLUCOSE MONITORING SYSTEM AND TEST STRIP (K102481)Apex BioTechnology Corp.2011-04-28
ONE TOUCH VERIO BLOOD GLUCOSE MONITORING SYSTEM (K093745)Lifescan, Inc.2011-02-11
ON CALL PLUS DIABETES MONITORING SOFTWARE (K101371)ACON Laboratories, Inc.2011-01-07
PC CARE BLOOD GLUCOSE DATA MANAGEMENT SOFTWARE (K100937)I-Sens, Inc.2010-12-21
WAVESENSE DIABETES MANAGER MODEL VERSION 1.3.4 (K101597)Agamatrix2010-10-18
ECHO TD-3227 DUAL BLOOD PRESSURE/BLOOD GLUCOSE METER (K092875)Taidoc Technology Corporation2010-08-13
AG-608 BLOOD GLUCOSE MONITORING SYSTEM AND AG-610 BLOOD GLUCOSE MONITORING SYSTEM (K093262)Andon Medical Co., Ltd.2010-07-13
FORA G30A BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4241 (K100732)Taidoc Technology Corporation2010-07-09
EASYPLUS MINI R9N SELF MONITORING BLOOD GLUCOSE SYSTEM MODEL EPS10031 (K101457)Eps Bio Technology Corp.2010-07-01
TD-4277 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 4277 (K100322)Taidoc Technology Corporation2010-06-28
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM550 (K092052)Bionime Corporation2010-06-18
FREESTYLE BLOOD GLUCOSE TEST STRIPS, MODELS 100-COUNT: 12401-01, 12101-21, 12101-22, 12101-23 (K092638)Abbott Diabetes Care, Inc.2010-06-15
ARKRAY DIABETES DATA MANAGEMENT SOFTWARE (SMBG VIEWER) (K093819)Arkray Factory USA, Inc.2010-06-09
SMARTLINK GOLD BLOOD GLUCOSE MONITORING SYSTEM (K100398)Standard Diagnostics, Inc.2010-06-09
GLUCOPHONE BLOOD GLUCOSE TEST SYSTEM, MODEL IGM-0025 (K091168)Infopia Co, Ltd.2010-05-27
FREESTYLE Lite Blood Glucose Monitoring System and Freestyle Freedom Lite Blood Glucose Monitoring System (K092602)Abbott Diabetes Care, Inc.2010-05-14
EASY TALK BLOOD GLUCOSE MONITORING SYSTEM MODEL: 6277 (K100560)Biotest Medical Corp.2010-05-12
FORA G31A/TD-4256A BLOOD GLUCOSE MONITORING SYSTEM AND FORA G31B/TD-4256B BLOOD GLUCOSE MONITORING SYSTEM (K094005)Taidoc Technology Corporation2010-05-05
ADVOCATE REDI-CODE DASH BLOOD GLUCOSE MONITORING SYSTEM MODEL TD-4276 (K093940)Taidoc Technology Corporation2010-04-23
SMARTEST PERSONA BLOOD GLUCOSE TEST SYTEM MODEL: 6277 (K100701)Biotest Medical Corp.2010-04-08
MODEL TD-3252 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM (K091555)Taidoc Technology Corporation2010-03-15
DIDGET WORLD REPORTS (K093930)Bayer Healthcare, LLC2010-03-12
U-RIGHT TD-4238 AND TD-4246 BLOOD GLUCOSE MONITORING SYSTEM FORA G31 BLOOD GLUCOSE MONITORING SYSTEM, TD-4256 BLOOD GLUC (K092902)Taidoc Technology Corporation2010-03-02
SOLOV2 BLOOD GLUCOSE MONITORING SYSTEM (K093764)Biotest Medical Corp.2010-03-02
ADVOCATE REDI-COD DUO BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM, MODEL TD-3223 (K093592)Taidoc Technology Corporation2010-02-25
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