BEUDAMED
    Product Code: NBW FDA class 2 21 CFR 862.1345

    System, Test, Blood Glucose, Over The Counter

    Clinical Chemistry

    The Over-The-Counter Blood Glucose Test System is a consumer-use in vitro diagnostic device that allows patients with diabetes to self-monitor blood glucose levels at home using a glucose meter and compatible test strips. Accurate blood glucose monitoring is essential for the management of diabetes mellitus. Classified as FDA Class 2, it requires 510(k) premarket clearance under regulation 862.1345 (Clinical Chemistry specialty).

    View on FDA
    510(k)s
    507
    FEI Numbers
    177
    Registration Numbers
    178
    Unique Applicants
    172
    Years Active
    24

    Basic Information

    Product Code
    NBW
    Device Class
    FDA class 2
    Regulation Number
    862.1345
    Medical Specialty
    Clinical Chemistry
    Review Panel
    CH
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 507 510(k) clearances via K numbers.

    K Number Device Name
    K243060 TeleRPM Gen2 Blood Glucose Monitoring System
    K240637 RIGHTEST Blood Glucose Monitoring System Max Tel
    K240640 Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring System
    K241787 CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System
    K222126 VivaChek™ Fad Blood Glucose Monitoring System, VivaChek™ Fad Smart Blood Glucose Monitoring System, VivaChek™ Fad Sync Blood Glucose Monitoring System
    K241304 WaveSense Jazz Blood Glucose Monitoring System
    K231679 CONTOUR® PLUS BLUE Blood Glucose Monitoring System
    K231192 RIGHTEST Blood Glucose Monitoring System Max Tel
    K233058 VivaChek Link Plus Blood Glucose Monitoring System
    K231476 TRUENESS™ AIR Blood Glucose Monitoring System; TRUENESS™ Blood Glucose Monitoring System
    K230625 ReliOn Premier BLU Blood Glucose Monitoring System
    K213131 Accu-Chek Guide Solo diabetes manager blood glucose monitoring system
    K223722 MIO Blood Glucose Monitoring System
    K222234 GlucoSure ADVANCE Link Blood Glucose Monitoring System
    K223293 CONTOUR® NEXT GEN Blood Glucose Monitoring System
    K220421 BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring System
    K213061 SuperCheck Pro Blood Glucose Monitoring System
    K212248 GlucoLeader Enhance 2 Blood Glucose Monitoring System
    K212140 GlucoSure Link Blood Glucose Monitoring System
    K202739 Bioland G-425-2V Blood Glucose Monitoring System, Bioland G-425-2 Blood Glucose Monitoring System
    K201037 FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System
    K203711 IWL2020 Blood Glucose Monitoring System
    K202534 MTM301 Blood Glucose and Ketone Monitoring System
    K213887 GAL-1A Plus Blood Glucose Monitoring System
    K193406 CardioChek Plus Test System; CardioChek Plus Home Test System
    K193407 Contour® next GEN Blood Glucose Monitoring System
    K201880 MultiSure GK Link Blood Glucose and Ketone Monitoring System
    K201394 CareSens N Feliz Blood Glucose Monitoring System, CareSens N Feliz BT Blood Glucose Monitoring System
    K202885 GlucoSure HT Plus Blood Glucose Monitoring System
    K201258 EASYMAX Tag Self-Monitoring Blood Glucose System
    K210687 CONTOUR® NEXT ONE Blood Glucose Monitoring System
    K203562 Finetest Lite Blood Glucose Monitoring System
    K201396 Finetest Lite Smart Blood Glucose Monitoring System
    K193340 GoChek Blood Glucose Monitoring System, GoChek Connect Blood Glucose Monitoring System
    K200277 Livongo Blood Glucose Monitoring System (BG1000)
    K191657 Bioland Blood Glucose Monitoring System
    K193475 OneTouch Verio Reflect Blood Glucose Monitoring System
    K192859 CareSens S Clear BT Blood Glucose Monitoring System
    K193590 CareSens S Fit BT Blood Glucose Monitoring System
    K192220 ReliOn Premier Classic Blood Glucose Monitoring System
    K191286 CONTOUR® NEXT Blood Glucose Monitoring System, CONTOUR® NEXT USB Blood Glucose Monitoring System, CONTOUR® NEXT ONE Blood Glucose Monitoring System, CONTOUR® NEXT EZ Blood Glucose Monitoring System, CONTOUR® NEXT LINK Wireless Blood Glucose Monitoring System
    K190189 MDT2 BLE Self-Monitoring Blood Glucose System
    K192175 On Call Express II Blood Glucose Monitoring System
    K191038 On Call Express Voice Blood Glucose Monitoring System
    K190579 TD-4183 Blood Glucose Monitoring System
    K190564 Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitoring System GM700SB
    K182428 GlucoLeader Enhance Blood Glucose Monitoring System
    K183306 GLUCOCARD® W onyx Blood Glucose Monitoring System
    K181070 iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+)
    K173140 VivaChek Ino Smart Blood Glucose Monitoring System, VivaChek Ino Sync Blood Glucose Monitoring System, VivaChek Ino Sound Blood Glucose Monitoring System, VivaChek Ino Plus Blood Glucose Monitoring System, VivaChek Ino Sound Simple Blood Glucose Monitoring System, VivaChek Ino Sound Bright Blood Glucose Monitoring System
    K181131 Accu-Chek Guide Me Blood Glucose Monitoring System
    K182046 Tyson Bio HS100 Blood Glucose Monitoring System, Tyson Bio HS100-B Blood Glucose Monitoring System
    K181588 POPS! one Blood Glucose Monitoring System
    K182047 Tyson Bio HT100-A Blood Glucose Monitoring System; Tyson Bio HT100-C Blood Glucose Monitoring System
    K182992 BGM014 Blood Glucose Monitoring System
    K181273 GLUCOCARD Shine Connex Blood Glucose Monitoring System, GLUCOCARD Shine Express Blood Glucose Monitoring System
    K181527 On Call Sure Blood Glucose Monitoring System, On Call Sure Sync Blood Glucose Monitoring System
    K182286 Oh'Care Lite Smart Blood Glucose Monitoring System
    K180866 CareSens S Fit Blood Glucose Monitoring System
    K182057 EasyMax BT Self-Monitoring Blood Glucose System
    K173658 Confidence Blood Glucose Monitoring System
    K173638 Rightest Blood Glucose Monitoring System Max, Rightest Blood Glucose Monitoring System Max Plus, GE Blood Glucose Monitoring System Max, GE Blood Glucose Monitoring System Max Plus
    K173505 FORA GTel Blood Glucose Monitoring System
    K173511 ActiveCare TD-4121 Blood Glucose Monitoring System
    K173139 Rightest Blood Glucose Monitoring System Wiz, Rightest Blood Glucose Monitoring System Wiz Plus
    K181316 POGO Automatic Blood Glucose Monitoring System
    K172723 Dario LC Blood Glucose Monitoring System
    K180196 On Call Express Mobile Blood Glucose Monitoring System
    K171480 NoCoding1 Plus Blood Glucose Monitoring System, VeraSens Blood Glucose Monitoring System
    K170464 StatStrip Xpress Blood Glucose Monitoring System
    K163087 PixoTest Blood Glucose Monitoring System
    K170614 CareSens N Premier Blood Glucose Monitoring System, CareSens N Premier BT Blood Glucose Monitoring System
    K160282 SD LipidoCare Professional System, SD LipidoCare Home System, SD LipidoCare BT Professional System, SD LipidoCare BT Home System
    K170241 GlucoDr.S Blood Glucose Monitoring System, GlucoDr.S BLE Blood Glucose Monitoring System, GlucoDr.S NFC Blood Glucose Monitoring System
    K170079 Tyson Bio HT100 Blood Glucose Monitoring System, Tyson Bio HT100-B Blood Glucose Monitoring System
    K170264 Gold AQ Blood Glucose Monitoring System
    K171941 FreeStyle Precision Neo Blood Glucose Test Strips
    K171822 NuvoMed Wireless Blood Glucose Monitoring System (Model BGM-6/0352)
    K171785 WowGoHealth Blood Glucose Monitoring System
    K170231 iHealth Align Gluco-Monitoring System (BG1); iHealth Wireless Smart Gluco-Monitoring System (BG5)
    K170064 GLUCOCARD W Blood Glucose Monitoring System
    K163159 Dario Blood Glucose Monitoring System
    K170143 GE Blood Glucose Monitoring System 180, GE Blood Glucose Monitoring System 182, Rightest Blood Glucose Monitoring System GM280, Rightest Blood Glucose Monitoring System GM280B,
    K162564 Medisign GH81 Blood Glucose Monitoring System, Medisign GH82 Blood Glucose Monitoring System, Medisign GH83 Blood Glucose Monitoring System, Medisign GH81 BT Blood Glucose Monitoring System, Medisign GH82 BT Blood Glucose Monitoring System, Medisign GH83 BT Blood Glucose Monitoring System
    K161790 iGlucose Blood Glucose Monitoring System
    K160179 VivaChek Ino Blood Glucose Monitoring System
    K162382 Smart Dongle Blood Glucose Monitoring System
    K162203 POGO Automatic Blood Glucose Monitoring System
    K152534 Medisign MM1000 BT Blood Glucose Monitoring System, Medisign MM1100 BT Blood Glucose Monitoring System, Medisign MM1200 BT Blood Glucose Monitoring System, Smart Diabetes Bluetooth Blood Glucose Monitoring System, Medisign MM 1000 BT MULTI Blood Glucose Monitoring System, Medisign MM 1100 BT MULTI Blood Glucose Monitoring System, Medisign MM 1200 BT MULTI Blood Glucose Monitoring System, Smart Diabetes Bluetooth Pro Blood Glucose Monitoring System
    K170267 BGM009 Plus Blood Glucose Monitoring System
    K153561 AG-607 Blood Glucose Monitoring System and AG-607 Multi Blood Glucose Monitoring System
    K162430 UniStrip1 Generic Blood Glucose Test Strips
    K162336 Contour Next EZ Blood Glucose Monitoring System
    K161299 BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring System
    K160742 NoCoding1 Plus Blood Glucose Monitoring System
    K161834 One Drop Blood Glucose Monitoring System
    K160682 CONTOUR NEXT ONE Blood Glucose Monitoring System
    K161738 FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone Monitoring Systems
    K160365 BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose Monitoring System
    K160944 ACCU-CHEK Guide Blood Glucose Monitoring System
    K153286 iHealth Align Gluco-Monitoring system
    K153278 Wireless Smart Gluco-Monitoring System
    K161867 On Call Pro Blood Glucose Monitoring System
    K160038 UniStrip1 Generic Blood Glucose Test Strips
    K152599 PRODIGY ASTRO Blood Glucose Monitoring System, PRODIGY ASTRO PRO Blood Glucose Monitoring System
    K160430 Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next Blood Glucose Monitoring System
    K153201 SD GlucoNavii Mentor BT Blood Glucose Monitoring System, SD GlucoNavii Mentor BT Multi Blood Glucose Monitoring System
    K160156 StatStrip Xpress Blood Glucose Monitoring System
    K152493 POGO Automatic Blood Glucose Monitoring System
    K152365 AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System
    K143548 TRUE METRIX GO Self Monitoring Blood Glucose System
    K153330 FreeStyle Precision Neo H Blood Glucose Monitoring System
    K143169 MyGlucoHealth Wireless System
    K150817 Dario Blood Glucose Monitoring System
    K152442 Freestyle Freedom Blood Glucose Monitoring Sytem
    K142785 PRODIGY iConnect Blood Glucose Monitoring System
    K151611 OneTouch Ultra Plus Flex Blood Glucose Monitoring System
    K150833 iHealth Align Gluco-Monitoring System, iHealth BG5 wireless Smart Gluco-Monitoring System, iHealth BG5L wireless Smart Gluco-Monitoring System
    K151658 Gmate Origin Blood Glucose Monitoring System
    K150942 Contour Next USB Blood Glucose Monitoring System
    K151265 SD GlucoNFC Blood Glucose Monitoring System, SD GlucoNFC Multi Blood Glucose Monitoring System
    K150299 Gmate SMART Blood Glucose Monitoring System
    K150396 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
    K140325 Joinsoon EON L Glucose Monitoring System and Joinsoon EON LS Glucose Monitoring System
    K141656 GMATE MINI BLOOD GLUCOSE MONITORING SYSTEM, GMATE STEP BLOOD GLUCOSE MONITORING SYSTEM
    K142928 FreeStyle Precision Neo Blood Glucose Monitoring System
    K151100 U-RIGHT TD-4116 Blood Glucose Monitoring System, U-RIGHT TD-4116 Pro Blood Glucose Monitoring System
    K151595 On Call Express Pro Blood Glucose Monitoring System
    K150274 GDH Professional Blood Glucose Monitoring System and GDH Professional LED Blood Glucose Monitoring System
    K151164 Assure Prism multi Blood Glucose Monitoring System
    K132929 SD GLUCONAVII MENTOR NFC MULTI BLOOD GLUCOSE MONITORING SYSTEM, AND SD GLUCONAVII MENTOR NFC BLOOD GLUCOSE MONITORING SYSTEM
    K150214 OneTouch Verio Flex Blood Glucose Monitoring System
    K141292 Rightest Blood Glucose Monitoring System GM700, Rightest Blood Glucose Monitoring System GM650, GE200 Blood Glucose Monitoring System, and GE300 Talking Blood Glucose Monitoring System
    K150531 FreeStyle Freedom Lite Blood Glucose Monitoring System
    K150332 FreeStyle Lite Blood Glucose Monitoring System
    K143387 GE333 Blood Glucose Monitoring System
    K140068 CARDIOCHEK PLUS TEST SYSTEM, CARDIOCHEK HOME TEST SYSTEM
    K141351 SUPERCHECK PLUS BLOOD GLUCOSE MONITORING SYSTEM, SUPER CHECK PLUS MULTI BLOOD GLUCOSE MONITORING SYSTEM
    K140150 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
    K143467 FORA GD43 Blood Glucose Monitoring System
    K141036 BGM009 BLOOD GLUCOSE MONITORING SYSTEM
    K132663 I-QARE DS-W BLOOD GLUCOSE MONITORING SYSTEM
    K141914 PRODIGY AUTOCODE EJECT BLOOD GLUCOSE MONITORING SYSTEM
    K150052 TRUE METRIX AIR Self-Monitoring Blood Glucose System, TRUE METRIX AIR PRO Professional Blood Gulcose Monitoring System
    K141867 ACCU-CHEK AVIVA CONNECT BLOOD GLUCOSE MONITORING SYSTEM
    K141862 HEALTH2SYNC MOBILE APPLICATION, HEALTH2SYNC SMART CABLE
    K140371 FREESTYLE PRECISION NEO BLOOD GLUCOSE: MONITORING SYSTEM, TEST STRIPS (50CT), TEST STRIPS (100CT)
    K141829 GLUCOVITAAL H1A BLOOD GLUCOSE MONITORING SYSTEM
    K131173 FIA Blood Glucose Monitoring System (G2)
    K142035 GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, RELION MICRO BLOOD GLUCOSE MONITORING SYSTEM
    K133741 ACCU-CHEK Performa Blood Glucose Monitoring System
    K140210 RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM ( GM720, RIGHTEST PROFESSIONAL BGMS GM720
    K132633 OKMETER DIRECT BLOOD GLUCOSE MONITORING SYSTEM
    K131230 GMATE SMART BLOOD GLUCOSE MONITORING SYSTEM, GMATE SMART APPLICATION
    K140100 TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRIX PRO PROFESSIONAL MONITORING BLOOD GLUCOSE SYSTEM
    K140141 LABONACHECK GLUPPY BLOOD GLUCOSE MONITORING SYSTEM
    K133260 MEDISIGN BLOOD GLUCSE MONITORING SYSTEM, MEDISIGN MULTI BLOOD GLUCOSE MONITORING SYSTEM
    K132180 IDEAL LIFE GLUCO-MANAGER BLOOD GLUCOSE MONITORING SYSTEM
    K130265 CONTOUR NEXT EZ BLOOD GLUCOSE METER
    K133790 IHEALTH ALIGN MINI GLUCO-MONITORING SYSTEM
    K133862 ACCU-CHEK AVIVA PLUS SYSTEM
    K132406 ELEMENTV BLOOD GLUCOSE MONITORING SYSTEM
    K133522 RIGHTEST DIABETES MANAGEMENT SOFTWARE AND ADAPTER (EXISTING CLEARED K113007),RIGHTEST NEW ADAPTERS-3,GE DIABETES MANAGEM
    K133389 EM40 SELF-MONITORING BLOOD GLUCOSE SYSTEM
    K133045 ELEMENT TM LITE BLOOD GLUCOSE MONITORING SYSTEM
    K133647 EMV3.1 PRO BLOOD GLUCOSE SYSTEM AND EMV3.1 SELF MONITORING BLOOD GLUCOSE SYSTEM
    K133509 EASY PLUS II BLOOD GLUCOSE MONITORING SYSTEM,EASY PLUS II MULTI BLOOD GLUCOSE MONITORING SYSTEM,SMARTEST PERSONA II BLOO
    K123517 GLUCOMENTOR BLOOD GLUCOSE MONITORING SYSTEM, GLUCOMENTOR MULTI BLOOD GLUCOSE MONITORING SYSTEM
    K131469 ACON ON CALL DIABETES MANAGEMENT SOFTWARE
    K132511 FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM
    K130284 ON CALL SHARP BLOOD GLUCOSE MONITORING SYSTEM
    K133346 SMARTLOG DIABETES MANAGEMENT SOFTWARE
    K132086 ON CALL EXPRESS BLOOD GLUCOSE MONITORING SYSTEM
    K132862 HEALTHPRO PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM
    K132966 GLUNEO LITE GLUCOSE MONITORING SYSTEM, GLUNEO LITE PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM
    K122340 PRODIGY CHOICE
    K132288 CARESENS N VOICE MULTI BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N VOICE MULTI BLOOD GLUCOSE METER
    K123090 GLB BENECHECK PREMIUM GLU MONITORING SYSTEM
    K132821 AGAMATRIX HEALTH MANAGER
    K113135 UNISTRIP 1
    K122338 PREFERRED BLOOD GLUCOSE MONITORING SYSTEM
    K132338 DA01 BLOOD GLUCOSE MONITORING SYSTEM
    K132272 GLOOKO DEVICE SYSTEM FOR GLOOKO APPLICATION
    K131013 FOCUS BLOOD GLUCOSE MONITORING SYSTEM, FOCUS PRO BLOOD GLUCOSE MONITORING SYSTEM
    K122370 CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE MONITOR
    K131363 ONETOUCH VERIO BLOOD GLUCOSE MONITORING SYSTEM
    K130244 DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM
    K130696 CARESENS N LINK BLOOD GLUCOSE MONITORING SYSTEM; CARESENS N LINK MULTI BLOOD BLUCOSE MONITORING SYSTEM
    K132072 TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRI PRO PROFESSIONAL MONITORING BLOOD GLUCOSE SYSTEM
    K122181 EBCHEK BLOOD GLUCOSE MONITORING SYSTEM
    K131419 ACURA PLUS MULTI BLOOD GLUCOSE MONITORING SYSTEM
    K131029 ACCU-CHEK AVIVA PLUS TEST STRIP
    K130181 GLUNEO BLOOD GLUCOSE MONITORING SYSTEM, AND PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM
    K130621 BROADMASTER HEALTHCARE SYSTEM
    K130657 LINKDR 2.0 DIABETES MANAGEMENT SOFTWARE
    K123559 SOLUSMOBILE BLOOD GLUCOSE MANAGMENT SYSTEM
    K130094 FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM
    K130295 LIPIDPRO LIPID PROFILE AND GLUCOSE MEASURING SYSTEM, LIPIDPRO PROFESSIONAL LIPID PROFILE AND GLUCOSE MEASURING SYSTEM.
    K123007 VERI-Q MGD-1001 BLOOD GLUCOSE MONITORING SYSTEM, VERI-Q PLUS MGD-1001 BLOOD GLUCOSE MONITORING SYSTEM
    K123087 TYSONBIO AC500, AC800 BLOOD GLUCOSE MONITORING SYSTEM, TYSONBIO AC500 AC800 PRO BLOOD GLUCOSE MONITORING SYSTEM
    K123016 VERI-Q SELF-TESTING AND VERI-Q PLUS MGD-2001 BLOOD GLUCOSE MONITORING SYSTEMS
    K124040 FORACARE GD20 BLOOD GLUCOSE MONITORING SYSTEM
    K122525 SMARTEST GLUCOWISE BLOOD GLUCOSE MONITORING SYSTEM, AND SMARTEST GLUCOSWISE MULTI BLOOD GLUCOSE MONITORING SYSTEM
    K130886 GLOOKO DEVICE SYSTEM FOR GLOOKO LOGBOOK+ APPLICATION
    K120989 TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRIX PROFESSIONAL MONITORING BLOOD GLUCOSE SYSTEM
    K130535 IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER APPLICATION
    K123935 IHEALTH BG5/BG5L WIRELESS SMART GLUCOSE MONITORING SYSTEM
    K123089 FREESTYLE AUTO-ASSIST SOFTWARE VERSON 2.0 WITH MODEL PRT24238-001
    K122307 DIAVUE PRUDENTIAL BLOOD GLUCOSE MONITORING SYSTEM
    K130138 SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEM
    K123136 GENESIS HEALTH RECORD SYSTEM, (GHRS)
    K113614 ACCU-CHECK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM
    K102751 LABONACHECK GLUPPY BLOOD GLUCOSE MONITORING SYSTEM
    K120708 ONETOUCH VERIO SYNC BLOOD GLUCOSE MONITORING SYSTEM
    K120558 ONETOUCH REVEAL DIABETES MANAGEMENT APPLICATION
    K123008 RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM GM700 GE GE200 BLOOD GLUCOSE MONITORING SYSTEM RIGHTEST BLOOD GLUCOSE MONITORIN
    K122142 GLOOKO LOGBOOK CHARTS
    K123010 ON CALL VIVID BLOOD GLUCOSE MONITORING SYSTEM
    K120866 DA01 BLOOD GLUCOSE MONITORING SYSTEM
    K120813 BLOOD GLUCOSE MONITORING SYSTEM
    K103542 GENSTRIP TEST STRIP MODEL 100-201
    K121679 ACCU-CHEK INFORM II BLOOD GLUCOSE MONITORING SYSTEM
    K120064 TEST, BLOOD GLUCOSE SYSTEM
    K112916 TYSONBIO MD100 BLOOD GLUCSE MONITORING ,TYSONBIO MD100 PRO BLOOD GLUCISE MONITORING SYSTEM
    K120423 BIONIME RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM650
    K113077 BIOLAND G-423 GLOOD GLUCOSE MONITORING SYSTEM
    K113192 HEALTHPRO BLOOD GLUCOSE MONITORING SYSTEM
    K121133 CARESENS N VOICE BLOOD GLUCOSE MONITORING SYSTEM
    K120649 AUTOSURE VOICE 3 PLUS BLOOD GLUCOSE MONITORING SYSTEM
    K121087 CONTOUR NEXT USB BLOOD GLUCOSE MONITORING SYSTEM
    K110074 HL 568 SELF MONITORING BLOOD GLUCOSE SYSTEM, HL 568BA SELF-MONIROTING BLOOD GLUCOSE SYSTEM
    K120183 ADVOCATE REDI-CODE+BMB-EA001S BLOOD GLUCOSE MONITORING SYSTEM
    K120351 CARESENS N POP BLOOD GLUCOSE MONITORING SYSTEM CARESENS N POP BLOOD GLUCOSE METER CARESENS N BLOOD GLUCOSE TEST STRIP CA
    K120568 FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEM
    K110737 RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM GM700
    K103329 DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM; DIATRUE PLUS BLOOD GLUCOSE TEST STRIP; DIATRUE GLUCOSE CONTROL SOLUTION
    K112638 NOVA MAX ONE BLOOD GLUCOSE MONITOR, NOVA MAX ONE BLOOD GLUCOSE TEST STRIPS
    K111456 MEDISIGN BLOOD GLUCOSE MONITORING SYSTEM
    K103044 AP-1010 AND AP-1020 BLOOD GLUCOSE MONITORING SYSTEM, MAJOR GLUCOSE CONTROL SOLUTION
    K113343 DIACHECK SMART/SUPERIOR BLOOD GLUCOSE MONITORING SYSTEM
    K111890 FORA DIAMOND PRIMA BLOOD GLUCOSE MONITORING SYSTEM, FORA DIAMOND MINI BLOOD GLUCOSE MONITORING SYSTEM
    K102383 MICRODOT & MICRODOT XTRA
    K110017 AG-608N BLOOD GLUCOSE MONITORING SYSTEM
    K113098 AUTOSURE VOICE II PLUS, AUTOSURE PLUS BLOOD GLUCOSE TEST STRIPS,CONTREX PLUS III
    K100437 AP-1000 BLOOD GLUCOSE MONITORING SYSTEM, MODEL AP-1000, MAJOR GLUCOSE CONTROL SOLUTION
    K113137 GLUCOSE TEST SYSTEM
    K101926 FORA D40 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM
    K112275 FORA PREMIUM V10 BLOOD GLUCOSE MONITORING SYSTEM
    K103544 IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER APPLICATION, REV D
    K112963 TD-4257 BLOOD GLUCOSE MONITORING SYSTEMS,TD 4257 MULTI BLOOD GLUCOSE MONITORING SYSTEMS
    K111932 IGLUCOSE SYSTEM
    K111509 SWEETSPOT DIABETES DATA MANAGEMENT SERVICE
    K103021 ELEMENT PLUS BLOOD GLUCOSE MONITORING SYSTEM
    K103115 PRODIGY DIABETES MANAGEMENT SOFTWARE
    K102063 HEALTH-E-CONNECT SYSTEM
    K112738 ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE
    K103396 COOL BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE METER, COOL CONTROL SOLUTION
    K110435 EASYGLUCO PLUS BLOOD GLUCOSE MONITORING SYSTEM
    K100806 DIACHECK BLOOD GLUCOSE MONITORING SYSTEM MODEL: PREMIUM
    K102816 GAL-1C BLOOD GLUCOSE MONITORING SYSTEM, GAL-1C TEST STRIPS
    K101631 FORA GD20 BLOOD GLUCOSE MONITORING SYSTEM, U-RUGHT TD-4252D BLOOD GLUCOSE MONITORING SYSTEM
    K101635 TD-4239 BLOOD GLUCOSE MONITORING SYSTEM AND TD-4239 MULTI BLOOD GLUCOSE MONITORING SYSTEM
    K101543 TYSONBIO BLOOD GLUCOSE MONITORING SYSTEM, MODELS AC100 AND AC200
    K102678 ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE, AG-608 SINGLE & AG-608 MULTI BLOOD GLUCOSE MONITORING SYSTEMS
    K101307 BLOOD GLUCOSE MONITORING SYSTEM, MODELS AG-6081 AND AG-6951
    K110571 TELCARE BLOOD GLUCOSE MONITORING SYSTEM, TEST STRIPS, CONTROL SOLUTIONS, TELSERVE-HOME USE, TELSERVE-PROFESSIONAL USE
    K093755 AG-695 SINGLE AND MULTI BLOOD GLUCOSE MONITORING SYSTEM/AG-696 SINGLE AND MULTI BLOOD GLUCOSE MONITORING SYSTEM
    K111029 FORA POCT MANAGMENT SYSTEM
    K101509 U-RIGHT TD-4279 BLOOD GLUCOSE MONITORING SYSTEM, FORA GD40/TD-4272 BLOOD GLUCOSE MONITORING SYSTEM
    K102345 EASYMAX T1 SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL EPS10042
    K102049 CLEVER CHOICE VOICE+ BLOOD GLUCOSE MONITORING SYSTEM
    K110709 ARK CARE DIABETES MANAGMENT SYSTEM
    K110948 HEALTH CARE SYSTEM SOFTWARE
    K102481 AUTOSURE VOICE 3 BLOOD GLUCOSE MONITORING SYSTEM AND TEST STRIP
    K093745 ONE TOUCH VERIO BLOOD GLUCOSE MONITORING SYSTEM
    K101371 ON CALL PLUS DIABETES MONITORING SOFTWARE
    K100937 PC CARE BLOOD GLUCOSE DATA MANAGEMENT SOFTWARE
    K101597 WAVESENSE DIABETES MANAGER MODEL VERSION 1.3.4
    K092875 ECHO TD-3227 DUAL BLOOD PRESSURE/BLOOD GLUCOSE METER
    K093262 AG-608 BLOOD GLUCOSE MONITORING SYSTEM AND AG-610 BLOOD GLUCOSE MONITORING SYSTEM
    K100732 FORA G30A BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4241
    K101457 EASYPLUS MINI R9N SELF MONITORING BLOOD GLUCOSE SYSTEM MODEL EPS10031
    K100322 TD-4277 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 4277
    K092052 RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM550
    K092638 FREESTYLE BLOOD GLUCOSE TEST STRIPS, MODELS 100-COUNT: 12401-01, 12101-21, 12101-22, 12101-23
    K100398 SMARTLINK GOLD BLOOD GLUCOSE MONITORING SYSTEM
    K093819 ARKRAY DIABETES DATA MANAGEMENT SOFTWARE (SMBG VIEWER)
    K091168 GLUCOPHONE BLOOD GLUCOSE TEST SYSTEM, MODEL IGM-0025
    K092602 FREESTYLE Lite Blood Glucose Monitoring System and Freestyle Freedom Lite Blood Glucose Monitoring System
    K100560 EASY TALK BLOOD GLUCOSE MONITORING SYSTEM MODEL: 6277
    K094005 FORA G31A/TD-4256A BLOOD GLUCOSE MONITORING SYSTEM AND FORA G31B/TD-4256B BLOOD GLUCOSE MONITORING SYSTEM
    K093940 ADVOCATE REDI-CODE DASH BLOOD GLUCOSE MONITORING SYSTEM MODEL TD-4276
    K100701 SMARTEST PERSONA BLOOD GLUCOSE TEST SYTEM MODEL: 6277
    K091555 MODEL TD-3252 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM
    K093930 DIDGET WORLD REPORTS
    K093764 SOLOV2 BLOOD GLUCOSE MONITORING SYSTEM
    K092902 U-RIGHT TD-4238 AND TD-4246 BLOOD GLUCOSE MONITORING SYSTEM FORA G31 BLOOD GLUCOSE MONITORING SYSTEM, TD-4256 BLOOD GLUC
    K093592 ADVOCATE REDI-COD DUO BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM, MODEL TD-3223
    K093475 BASESENS BLOOD GLUCOSE MONITORING SYSTEM
    K092894 EASYMAX V SELF MONITORING BLOOD GLUCOSE SYSTEM
    K093789 INTOUCH DIABETES
    K093712 FORA G71A BLOOD GLUCOSE MONITORING SYSTEM, TD-4274 BLOOD GLUCOSE MONITORING SYSTEM
    K093635 MODELS FORA V30 AND TD-4242 BLOOD GLUCOSE MONITORING SYSTEMS
    K093005 FORA G72 BLODO GLUCOSE MONITORING SYSTEM/TD-4264 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4264
    K090609 OKMETER MATCH BLOOD GLUCOSE MONITORING SYSTEM
    K091765 EBCARRYON BLOOD GLUCOSE MONITORING SYSTEM
    K091547 NOVA MAX PLUS BLOOD GLUCOSE AND B-KETONE MONITOR SYSTEM, NOVA MAX PLUS B-KETONE CONTROL SOLUTIONS, NOVA MAX BLOOD GLUCOS
    K093035 FORA V10 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4244
    K092099 NO-CODING BLOOD GLUCOSE MONITORING SYSTEM, MODELS TD-4251, TD-4252, TD-4253 AND TD-4254
    K082683 SD CHECK GOLD
    K090628 DIDGET BLOOD GLUCOSE METER, MODEL 6181; CONTOUR BLOOD GLUCOSE TEST STRIPS, MODEL 7080
    K090405 LIPIDPRO SYSTEM
    K083273 MICRODOT XTRA
    K091157 GLUCO LAB AUTO CODING, MODEL IGM-0022
    K091815 SUPERCHECK 1 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 6268
    K092887 EASYPLUS MINI MASTERDRIVER SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL EPS09009
    K090653 POCKETCHEM EZ BLOOD GLUCOSE MONITORING SYSTEM
    K090712 EOCENE SYSTEM
    K091898 BLOOD GLUCOSE MONITORING SYSTEM, MODEL FORA G90/TD-4234
    K091820 CONTOUR USB BLOOD GLUCOSE METER, GLUCOSE TEST STRIPS; GLUCOFACTS DELUX DIABETES MANAGEMENT SYSTEM
    K091481 EASYPLUS MINI R13N SELF MONITORING BLOOD GLUCOSE SYSTEM
    K090332 ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 46001
    K091229 GLUCOMANAGER DATA MANAGEMENT SOFTWARE
    K091296 POLYTEL GMA, MODELS PWR-08-67, PWR-08-07, PWR-08-09
    K090389 AP-1000 BLOOD GLUCOSE MONITORING SYSTEM
    K090188 U-RIGHT TD-4227 NO CODING BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4222
    K090404 FORE V10 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4244, FOREA V12 BLODO GLUCOSE MONITORING SYSTEM, MODEL TD-4247
    K090629 EASY STEP AND DIACHEX+ PRO BLOOD GLUCOSE MONITORING SYSTEMS
    K090187 FORA G30 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4241
    K083628 GLUCODR AUTO SYSTEM
    K090185 CLEVER CHEK BLOOD GLUCOSE MONITORING SYSTEM; ACHTUNG BLOOD GLUCOSE MONITORING SYSTEM
    K090057 ON-CALL PLUS BLOOD GLUCOSE MONITORING SYSTEM
    K090495 TRUEBALANCE BLOOD GLUCOSE SYSTEM
    K090536 FORA V12 NO-CODING BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4247
    K062187 BETACHEK GLUCOSE TEST
    K083263 SYMCARE DIABETES MANAGEMENT PROGRAM
    K082328 GLUCODR PLUS SYSTEM, MODEL AGM-3000
    K082201 G5 INFINITY BLODO GLUCOSE MONITORING SYSTEM WITH MODEL IGM, 0024A
    K080853 DUO-CARE BLOOD GLUCOSE AND BLOOD PRESSURE MONITOR SYSTEM
    K083468 CARESENS N BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N METER, MODEL GM5051A OR GM5051B OR GM5051C (COLOR)
    K083265 JAZZ WIRELESS BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-03381
    K081796 EASYPLUS MINI R2N SELF MONITORING GLUCOSE TEST SYSTEM
    K083099 EASYMAX N SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL: EPS08008
    K082521 EASY2CHECK BLOOD GLUCOSE AND BLOOD PRESSURE MONITORING SYSTEM
    K081703 MYGLUCOHEALTH GLUCOSE MONITORING SYSTEMS
    K082020 ENVISION BLOOD GLUCOSE TEST SYSTEM
    K081715 FORA TD-4244 & TD-4245 BLOOD GLUCOSE MONITORING SYSTESM
    K082169 PRO GLUCOSE TEST STRIP
    K081975 RELION ULTIMA ADVANCE BLOOD GLUCOSE MONITORING SYSTEM MODELS, BGMS 71030-01 STRIPS: 7103-01 (20 COUNT)
    K082513 ONETOUCH VITA BLOOD GLUCOSE MONITORING SYSTEM
    K080923 CARESENS BLOOD GLUCOSE MONITORING SYSTEM; CARESENS II METER, MODEL GM505C; CARESENS POP METER, MODEL GM505EA OR GM505EB
    K082486 GLUCOFACTS EXPRESS DIABETES MANAGEMENT SOFTWARE
    K082618 ULTRA TRAK PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-455
    K081451 RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM100
    K081450 RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM110
    K080960 PRECISION XCEED PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM WITH MODELS BGMS:70900-03, 70090-02, G3CH STRIPS
    K081726 TYSONBIO LINK HEALTH MANAGEMENT SYSTEM
    K080641 TRUERESULT BLOOD GLUCOSE SYSTEM E4H01-81
    K080710 TRUE2GO BLOOD GLUCOSE SYSTEM, MODEL F4H01-81
    K081957 U-RIGHT TD-4247 BLOOD GLUCOSE MONITORING SYSTEM
    K073030 AG-605 BLOOD GLUCOSE MONITORING SYSTEM
    K081389 ACCU-CHEK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM
    K080538 IDEAL LIFE POD (MODEL ILP 0001)
    K072854 DIACHEX BASIC BLOOD GLUCOSE MONITORING SYSTEM, DIACHEX SUPERB BLOOD GLUCOSE MONITORING SYSTEM
    K080283 IDEAL LIFE GLUCO-MANAGER GMM 0001 BLOOD GLUCOSE MONITORING SYSTEM
    K081144 CLEVER CHEK AUTO-CODE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4243
    K081318 ONETOUCH ZOOM DIABETES MANAGEMENT PROGRAM
    K080014 CLEVER CHEK TD-3250C BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM
    K080501 SURECHEK EDGE BLOOD GLUCOSE MONITORING SYSTEM, MODEL SMS-4240
    K073231 ONETOUCH ULTRALINK BLOOD GLUCOSE MONITORING SYSTEM
    K072905 3TEST SUPREME GLUCOSE MONITORING SYSTEM
    K073492 DIACHEX+DETERMINE BLOOD GLUCOSE MONITORING SYSTEM, DIACHEX-INFINITY BLOOD GLUCOSE MONITORING SYSTEM
    K073494 CLEVER CHEK BLOOD GLUCOSE MONITORING SYSTEM, MODELS TD-4209, -4222, -4225 AND -4226 AND ACHTUNG BLOOD GLUCOSE MONITORING
    K073137 GLUCOSURE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90011E1
    K073699 MCT-DIABETES
    K072441 EZ SCAN PLUS BLOOD GLUCOSE MONITORING SYSTEM
    K072369 EVOLUTION BLOOD GLUCOSE MONITORING SYSTEM
    K073118 PRODIGY VOICE BLOOD GLUCOSE MONITORING SYSTEM
    K073119 CLEVER CHEK MODEL TD-4232 BLOOD GLUCOSE MONITORING SYSTEM
    K072274 MAJOR III BLOOD GLUCOSE MONITORING SYSTEM
    K072054 RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM310
    K073573 WAVESENSE KEYNOTE CODELESS BLOOD GLUCOSE MONITORING SYSTEM
    K072784 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4227, CLEVER CHEK TD-4227 BLOOD GLUCOSE MONITORING SYSTEM
    K070053 EASYPLUS MINI SELF MONITORING GLUCOSE TEST SYSTEM, MODELS R1 AND R2
    K071493 CLEVER CHEK TD-4209 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4209, TD-4222, TD-4225
    K072543 ONETOUCH SELECT BLOOD GLUCOSE MONITORING SYSTEM
    K072039 ADVOCATE REDI-CODE BLOOD GLUCOSE MONITORING SYSTEM, MODELS TD-4223E; TD-4223F
    K072413 MODIFICATION TO: JAZZ BLOOD GLUCOSE MONITORING SYSTEM
    K072489 REVOLUTION TD-4229 BLOOD GLUCOSE MONITORING SYSTEM
    K071507 PTS PANELS CHOL+HDL+GLU PANEL TEST STRIPS
    K063771 GLUCOCARD X-METER BLOOD GLUCOSE MONITORING SYSTEM
    K071393 JAZZ BLOOD GLUCOSE MONITORING SYSTEM
    K062377 MEDAPPS REMOTE PATIENT MONITORING, MODEL MA 100
    K070559 POLYMAP PWR-08-03
    K070524 MICRODOT BLOOD GLUCOSE MONITORING SYSTEM
    K070941 CLEVER CHEK HEALTH CARE SYSTEM SOFTWARE, VERSION 1.0
    K070255 NOVA MAX BLOOD GLUCOSE MONITOR SYSTEM, 90001,90002
    K070585 ACCU-CHEK PERFORMA SYSTEM
    K070239 MAXIMED EXICHEK TD-4224 BLOOD GLUCOSE MONITORING SYSTEM
    K062395 ACCU-CHEK SMART PIX
    K070593 TRACKRECORD DATA MANAGEMENT SOFTWARE
    K062538 EASY CHECK BLOOD GLUCOSE MONITORING SYSTEM
    K070850 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM
    K070641 ADVOCATE DUO BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM, MODEL TD-3223
    K070472 CLEVER CHEK TD-4230 BLOOD GLUCOSE MONITORING SYSTEM, RD-4230, SURECHEK BLOOD GLUCOSE MONITORING SYSTEM, SMS-4230
    K070088 ASSURE 4 BLOOD GLUCOSE MONITORING SYSTEM
    K062567 RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM
    K063026 OK METER BLOOD GLUCOSE MONITORING SYSTEM
    K070017 PTS PANELS METABOLIC CHEMISTRY PANEL TEST STRIPS
    K063409 LIBERTY BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-0067
    K062800 CLEVER CHEK TD-3213/ CLEVER CHEK TD-3215/ DR. T TD-3216/ CLEVER CHEK TD-3217/ CLEVER CHEK TD-3250 BLOOD GLUCOSE PLUS BLO
    K062555 EBSENSOR BLOOD GLUCOSE MONITORING SYSTEM, MODEL EB-G
    K063068 FERRARA BLOOD GLUCOSE MONITORING SYSTEM, MODEL 631100
    K062770 COPILOT HEALTH MANAGEMENT SYSTEM
    K063212 CLEVER CHEK TD-4231 AND TD-4223 BLOOD GLUCOSE MONITORING SYSTEM
    K062347 ASCENSIA BREEZE 2 BLOOD GLUCOSE MONITORING SYSTEM
    K062434 ZERO-CLICK DATA MANAGEMENT SYSTEM, MODEL 8000-01528
    K061234 GLUCOPLUS BLOOD GLUCOSE MONITORING SYSTEM
    K062829 DIACHEX BLOOD GLUCOSE MONITORING SYSTEM
    K062235 EASY CHECK TD-4209 BLOOD GLUCOSE MONITORING SYSTEM; CLEVER CHECK TD-4222, TD-4225, TD-4226 BLOOD GLUCOSE MONITORING SYST
    K062058 ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151; REAGENT STRIP, MODEL 7080
    K062195 MODIFICATION TO ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM
    K060620 ACCU-CHEK AVIVA TEST STRIPS
    K060793 ELEMENT BLOOD GLUCOSE TEST SYSTEM
    K060467 PRODIGY BLOOD GLUCOSE TEST SYSTEM
    K061181 ACHTUNG BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4207
    K053593 PRODIGY
    K052818 EZ SMART-168 GLUCOSE MONITORING SYSTEM
    K061328 THINK POSITIVE DIABETES MANAGEMENT SYSTEM (T+DIABETES SYSTEM)
    K052469 GLUCOPACK
    K061118 ONETOUCH ULTRAMINI BLOOD GLUCOSE MONITORING SYSTEM
    K051651 G4, MODEL IGM-0004
    K060470 ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151; ASCENSIA MICROFILL REAGENT STRIP, MODEL 7080
    K051839 FREE-STYLE FREEDOM BLOOD GLUCOSE MONITORING SYSTEM, MODEL 11001
    K053312 EASYMATE BLOOD GLUCOSE MONITORING SYSTEM
    K053635 MODIFICATION TO RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM
    K052762 LIBERTY BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-0067
    K053529 ONETOUCH ULTRA 2 BLOOD GLUCOSE MONITORING SYSTEM
    K052208 GLUCOSE PILOT
    K052343 E-SAN BLUETOOTH CRADLE
    K052108 SEIN BLOOD GLUCOSE AND BLOOD PRESSURE MONITOR SYSTEM, MODEL BGP-100
    K050985 GLUCODR SUPERSENSOR SYSTEM
    K051514 ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 460002
    K051802 FREESTYLE CONNECT BLOOD GLUCOSE MONITORING SYSTEM
    K051936 CLEVER CHECK TD-3215/DR. T TD-3216 BLOOD GLUCOSE AND BLOOD PRESSURE MEASUREMENT SYSTEMS
    K051854 CLEVER CHEK TD-4225, MODEL TD-4225
    K050224 3TEST GLUCOSE MONITORING SYSTEM
    K051147 SIDEKICK BLOOD GLUCOSE TEST SYSTEM
    K050500 FREESTYLE 600 BLOOD GLUCOSE MONITORING SYSTEM
    K043340 EZ SMART
    K051213 PRECISION XTRA PLUS OR OPTIUM PLUS, BLOOD GLUCOSE TEST STRIPS
    K043543 BLOOD GLUCOSE MONITORING SYSTEM
    K042795 CLEVER CHEK TD-3213
    K042678 RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM
    K043311 ASCENSIA ELITE DIABETES CARE SYSTEM
    K043158 ASCENSIA BRIO BLOOD GLUCOSE MONITORING SYSTEM
    K042005 ACHTUNG TD-4207, CLEVER CHEK TD-4209, CLEVER CHEK TD-4222
    K040848 EZ SMART
    K041750 PTS PANELS CHOL+GLU TEST PANEL
    K040678 EUSURE BLOOD GLUCOSE MONITORING SYSTEM
    K041107 TAIDOC CHECK
    K040603 PARADIGM LINK BLOOD GLUCOSE METER
    K040814 MODIFICATION TO PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM
    K040670 MODIFICATION TO TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER, TEST STRIPS AND GLUCOSE CONTROL
    K040628 PRECISION LINK DIABETES DATA MANAGEMENT SYSTEM
    K032657 TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST STRIPS, AND GLUCOSE CONTROL SOLUTIONS (LOW AND HIGH)
    K033845 PRECISION XCEED DIABETES MONITORING SYSTEM
    K031260 FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM, MODELS 11001, 16000, AND 16005
    K032029 BTG SMARTEST GLUCOSE TEST SYSTEM
    K032985 GLUCOLEADER ENHANCE SELF-MONITORING OF BLOOD GLUCOSE SYSTEM
    K031501 EASYGLUCO, MODEL IGM0002
    K032552 ACCU-CHEK ADVANTAGE SYSTEM
    K023279 GLUCOLEADER VALUE
    K030703 TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER AND TRUE TRACK SMART SYSTEM BLOOD GLUCOSE TEST STRIPS
    K031843 MODIFICATION TO EVENCARE BLOOD GLUCOSE MONITORING SYSTEM
    K023256 PRECISION XTRA/MEDISENSE OPTIUM/PRECISION EASY/MEDISENSE OPTIUM EASY BLOOD GLUCOSE TEST STRIP WITH TRUE MEASURE TECHNOLO
    K024194 ONE TOUCH ULTRA AND ONE TOUCH INDUO BLOOD GLUCOSE MONITORING SYSTEMS
    K024234 ASCENSIA GLUCOFACTS; ASCENSIA GLUCOFACTS PROFESSIONAL
    K023832 SURESTEP HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM
    K023219 BECTON DICKINSON DIABETES SOFTWARE
    K023584 ASCENSIA DEX 2 DIABETES CARE SYSTEM
    K022545 GLUCOBALANCE DATA MANAGEMENT SOFTWARE, MODEL 555020
    K022581 BECTON DICKINSON LOGIC BLOOD GLUCOSE MONITORING SYSTEM
    K022724 SURESTEP BLOOD GLUCOSE MONITORING SYSTEM
    K022182 MEDISENSE PRECISION EASYBLOOD GLUCOSE MONITORING SYSTEM, MEDISENSE OPTIUM EASYBLOOD GLUCOSE MONITORING SYSTEM
    K021819 ONE TOUCH ULTRASMART BLOOD GLUCOSE MONITORING SYSTEM
    K022171 ACCU-CHEK COMPACT SYSTEM
    K021827 MODIFICATION TO ACCU-CHEK ACTIVE SYSTEM
    K021513 ACCU-CHEK ADVANTAGE MODULE
    K020866 FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM
    K021448 MODIFICATION TO ACCU-CHEK ACTIVE SYSTEM
    K020210 GLUCOMETER DEX BLOOD GLUCOSE SYSTEM (MODIFIED)
    K020208 GLUCOMETER ELITE DIABETES CARE SYSTEM (MODIFIED)
    K012975 SOF-TACT DIABETES MANAGEMENT SYSYEM; SOF-TACT BLOOD GLUCOSE TEST STRIP; PRECISION CONTROL SOLUTIONS
    K014167 LIBERTY BLOOD GLUCOSE MONITORING SYSTEM
    K014099 BIOSCANNER PLUS
    K012324 ACCU-CHEK ACTIVE TEST SYSTEM
    K012014 MODIFICATION TO BLOOD GLUCOSE MONITORING SYSTEM
    K013203 BIOSCANNER BEYOND GLUCOSE ANALYZER AND TEST STRIPS
    K011240 EVENCARE BLOOD GLUCOSE MONITORING SYSTEM
    K012205 GLUCOMETER DEX TEST SENSOR
    K010039 QUICKTEK BLOOD GLUCOSE SYSTEM, QUICKTEK BLOOD GLUCOSE METER, QUICKTEK BLOOD GLUCOSE STRIPS, QUICKTEK CONTROL SOLUTION
    K012210 MODIFICATION TO ACCU-CHEK INFORM METER
    K011616 INDUO BLOOD GLUCOSE METER
    K011738 ACCU-CHEK ACTIVE SYSTEM
    K010553 PRECISION XTRA BLOOD GLUCOSE TEST STRIP WITH TRUEMEASURE TECHNOLOGY
    K010403 PRESTIGE IQ BLOOD GLUCOSE TEST SYSTEM, MODEL 507400, 537600, 550600, 561700, 563700

    FEI Numbers

    This FDA classification entry is associated with 177 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 178 registration numbers. Click on an entry to view related FDA registrations.