| GLUCOSE REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMS (K033055) | Diamond Diagnostics, Inc. | 2004-01-30 |
| RANDOX RX DAYTONA (K024014) | Randox Laboratories, Ltd. | 2003-12-04 |
| ONE TOUCH BASIC/PROFILE/ONE TOUCH II TEST STRIPS (K031472) | Lifescan, Inc. | 2003-08-05 |
| MODIFICATION TO HYPOGUARD ADVANCE BLOOD GLUCOSE MONITORING SYSTEM (K031388) | Hypoguard USA, Inc. | 2003-05-22 |
| EXPRESS BLOOD GLUCOSE MONITORING SYSTEM (K024347) | Hypoguard USA, Inc. | 2003-03-28 |
| ASCENSIA BREEZE BLOOD GLUCOSE METER (K024062) | Bayer Corp. | 2003-03-03 |
| SURESTEPPRO/SURESTEPFLEXX PROFESSIONAL BLOOD GLUCOSE MANAGEMENT SYSTEM (K023194) | Lifescan, Inc. | 2002-10-24 |
| BACTON DICKINSON LATITUDE BLOOD GLUCOSE MONITORING SYSTEM (K022580) | Becton, Dickinson & CO | 2002-10-09 |
| IQM (INTELLIGENT QUALITY MANAGEMENT) ON THE GEM PREMIER 3000, CVP (CALIBRATION VALIDATION PRODUCT) (K022158) | Instrumentation Laboratory CO | 2002-09-10 |
| EXCELSIOR 3UL TEST STRIPS, FOR USE WITH THE HOME DIAGNOSTICS, INC. PRESTIGE LX AND IQ BLOOD GLUCOSE SYSTEMS (K021781) | Chay Medical, LLC | 2002-08-30 |
| ONETOUCH PROFILE BLOOD GLUCOSE MONITORING SYSTEM (K021943) | Lifescan, Inc. | 2002-06-28 |
| HEMOCUE GLUCOSE 201 SYSTEM, ARTICLE NUMBER 120706 (K020935) | Hemocue, Inc. | 2002-04-03 |
| DIABETES ASSISTANT SOFTWARE (K014139) | Roche Diagnostics Corp. | 2002-03-21 |
| EXCELSIOR TEST STRIPS, FOR USE WITH THE HOME DIAGNOSTICS, INC. (K013342) | Chay Medical, LLC | 2002-02-15 |
| HYPOGUARD ADVANCE BLOOD GLUCOSE MONITORING SYSTEM (K020232) | Hypoguard USA, Inc. | 2002-02-12 |
| WIENER LAB. GLICEMIA ENZIMATICA AA MODELS 1 X 250 ML CAT. #1400106; 4 250 ML CAT. # 1400107; WIENER LAB. GILICEMIA ENZCA (K011953) | Wiener Laboratories Saic | 2001-12-21 |
| ONE TOUCH FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM, ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM (K011479) | Inverness Medical Innovations, Inc. | 2001-11-30 |
| BIOSCANNER 2000 (K013068) | Polymer Technology Systems, Inc. | 2001-11-20 |
| MODIFICATION TO GLUCOSURE BGM SYSTEM, MODEL 221100 (K011233) | Apex BioTechnology Corp. | 2001-05-18 |
| GEM PREMIER 3000- ADDITION OF GLUCOSE AND LACTATE AS NEW PARAMETERS (K010520) | Instrumentation Laboratory CO | 2001-05-07 |
| ATLAST DATA MANAGEMENT SOFTWARE (DMS) (K010605) | Amira Medical, Inc. | 2001-05-07 |
| RANDOX GLUCOSE (GOD/PAP) (K003346) | Randox Laboratories, Ltd. | 2001-03-15 |
| PERSONAL GLUCOSE CONTROL CHARTING SYSTEM (K002688) | Lxn Corp. | 2001-02-01 |
| GLUCOSURE BLOOD GLUCOSE MONITORING SYSTEM (K002621) | Apex BioTechnology Corp. | 2001-01-22 |
| GLUCOSMART BLOOD GLUCOSE MONITORING SYSTEM (K002624) | Apex BioTechnology Corp. | 2001-01-22 |
| EHC400 DESKTOP PATIENT STATION; ECH600 CARE PROVIDER STATION (K003257) | Cybercare Technologies, Inc. | 2000-12-22 |
| SATURN BLOOD GLUCOSE MONITORING TEST STRIP (K001441) | Lifescan, Inc. | 2000-12-18 |
| I-STAT PORTABLE CLINICAL ANALYZER, MODEL 300 (K001387) | I-Stat Corp. | 2000-10-05 |
| CAMIT DIABETES MANAGEMENT SOFTWARE (K001907) | Roche Diagnostics Corp. | 2000-09-05 |
| ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM (K002134) | Selfcare, Inc. | 2000-08-07 |
| GENERIC BLOOD GLUCOSE TEST STRIP (K001092) | Inbios Intl., Inc. | 2000-07-26 |
| MODIFICATION TO FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM (K001427) | Selfcare, Inc. | 2000-06-02 |
| FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM (K000583) | Selfcare, Inc. | 2000-03-17 |
| ACCU-CHEK ADVANTAGE METER (K000365) | Roche Diagnostics Corp. | 2000-02-23 |
| AVL OPTI CRITICAL CARE ANALYZER (K993837) | Avl Scientific Corp. | 1999-12-16 |
| HEALTHBUDDY WITH DEVICE CONNECT [GLUCOSE METER] (K993128) | Health Hero Network, Inc. | 1999-11-23 |
| FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM (K993632) | Selfcare, Inc. | 1999-11-12 |
| PRESTIGE LX BLOOD GLUCOSE TEST SYSTEM (K992988) | Home Diagnostics, Inc. | 1999-09-24 |
| EXCEL GE BLOOD GLUCOSE TEST STRIPS & CODE STRIP (K991480) | Selfcare, Inc. | 1999-09-17 |
| GO GLUCOSE MONITORING SYSTEM (K991754) | Lxn Corp. | 1999-09-08 |
| DUET II GLUCOSE CONTROL MONITORING SYSTEM (K990942) | Lxn Corp. | 1999-08-02 |
| GLUCOMETER ELITE XL BLOOD GLUCOSE METER, GLUCOMETER ELITE BLOOD GLUCOSE TEST SYSTEMS (K990649) | Bayer Corp. | 1999-07-09 |
| PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM, PRECISION BLOOD GLUCOSE TEST STRIPS, PRECISION XTRA B-KETONE TEST ST (K983504) | Medisense, Inc. | 1999-07-09 |
| GLUCOMETER ELITE TEST STRIPS (K991242) | Bayer Corp. | 1999-06-30 |
| DADE BEHRING QUIKLYTE METABOLYTE CARTRIDGE, MODEL DIMENSION(R) XL OR RXL (K983344) | Dade Behring, Inc. | 1999-06-22 |
| SURESTEP BLOOD GLUCOSE MONITORING SYSTEM (K984261) | Lifescan, Inc. | 1999-05-21 |
| IN TOUCH DIABETES MANAGEMENT SOFTWARE (K984527) | Lifescan, Inc. | 1999-04-29 |
| FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM (K990939) | Selfcare, Inc. | 1999-04-20 |
| GLUCOMETER ELITE XL BLOOD GLUCOSE METER (K984006) | Bayer Corp. | 1999-03-18 |
| AMIRA MEDICAL ATLAST BLOOD GLUCOSE MONITORING SYSTEM (K982076) | Amira Medical, Inc. | 1998-12-10 |
| PRECISION PCX POINT OF CARE MANAGEMENT SYSTEM , QC MANAGER DATA MANAGER SYSTEM, PRECISION G PLUS BLOOD GLUCOSE TEST ST (K982303) | Medisense, Inc. | 1998-12-08 |
| SENSOREX BLOOD GLUCOSE MONITORING SYSTEM (K980573) | Chronimed, Inc. | 1998-07-30 |
| CARESIDE GLUCOSE (K981183) | Exigent Diagnostics, Inc. | 1998-05-07 |
| ONE TOUCH II HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM (K974451) | Lifescan, Inc. | 1998-01-26 |
| MTM BIOSCANNER 1000 TEST SYSTEM CONSISTING OF MTM BIOSCANNER 1000 METER, MTM BIOSCANNER G TEST STRIP, NORMAN GLUCOSE CON (K972669) | Polymer Technology Systems, Inc. | 1998-01-22 |
| GLUCOCHEK POCKETLAB II BLOOD GLUCOSE SYSTEM (K971653) | Clinical Diagnostics, Inc. | 1998-01-02 |
| ONE TOUCH II HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM DATA DOCK (K972473) | Lifescan, Inc. | 1997-12-16 |
| DUET GLUCOSE CONTROL MONITORING SYSTEM (K973140) | Lxn Corp. | 1997-10-31 |
| GLUCOSITE TEST SYSTEM (K971145) | Gds Technology, LLC | 1997-09-17 |
| AVL OMNI ANALYZER (K972733) | Avl Scientific Corp. | 1997-09-09 |
| PRECISION QID BLOOD GLUCOSE TEST STRIP, PRECISION G BLOOD GLUCOSE TEST STRIP (K971812) | Medisense, Inc. | 1997-08-08 |
| ELECT II BLOOD GLUCOSE MONITORING SYSTEM (K970707) | Selfcare, Inc. | 1997-06-20 |
| SURESTEP PRO BLOOD GLUCOSE MONITORING SYSTEM (K970556) | Lifescan, Inc. | 1997-05-12 |
| LIQUID GLUCOSE (OXIDASE) REAGENT SET (K970781) | Pointe Scientific, Inc., | 1997-04-21 |
| SUPREME II METER (K963544) | Chronimed, Inc. | 1997-02-20 |
| PRECISION G BLOOD GLUCOSE TESTING SYSTEM (K963676) | Medisense, Inc. | 1997-02-20 |
| GLUCOMETER ELITE BLOOD GLUCOSE METER (K964630) | Bayer Corp. | 1997-02-10 |
| GLUCOMETER DEX DIABETES CARE SYSTEM (K963500) | Bayer Corp. | 1997-01-21 |
| SIGMA DIAGNOSTICS GLUCOSE REAGENT (K963535) | Sigma Diagnostics, Inc. | 1997-01-17 |
| PRESTIGE BLOOD GLUCOSE MONITORING SYSTEM,METER,TEST STRIPS & PRESTIGE HIGH AND LOW GLUCOSE CONTROL (K960855) | Home Diagnostics, Inc. | 1996-11-07 |
| AMD HOME HEALTH MONITORING SYSTEM (K960337) | Advanced Medical Devices, Inc. | 1996-09-24 |
| ELECT BLOOD GLUCOSE MONITORIG SYSTEM (K961985) | Selfcare, Inc. | 1996-09-05 |
| SAFESTRIP (K955107) | Firehouse Medical, Inc. | 1996-08-16 |
| PRECISION QID BLOOD GLUCOSE TEST STRIP (K962295) | Medisense, Inc. | 1996-07-26 |
| CHEMCARD GLUCOSE TEST (K943503) | Chem-Elec, Inc. | 1996-07-23 |
| SELFCARE BLOOD GLUCOSE TEST STRIPS FOR THE EXACTECH SYSTEM (K960053) | Selfcare, Inc. | 1996-06-28 |
| LXN BLOOD GLUCOSE TEST SYSTEM (K960034) | Lxn Corp. | 1996-06-28 |
| EXACTECH RSG BLOOD GLUCOSE TESTING SYSTEM (K961337) | Medisense, Inc. | 1996-06-21 |
| EKTACHEM CLINICAL CHEMISTRY SLIDE GLUCOSE (GLU) (K955286) | Johnson & Johnson Clinical Diagnostics, Inc. | 1996-05-17 |
| ACCU-CHEK INSTANT PLUS G-C/DM BLOOD GLUCOSE MONITORING SYSTEM (K944459) | Boehringer Mannheim Corp. | 1996-04-17 |
| GLUCOCHEK POCKETLAB (K951457) | Clinical Diagnostics, Inc. | 1996-02-22 |
| ACCU-CHEK ALPHA MONITOR & ACCU-CHEK GLUCOSE TEST STRIPS (K952875) | Boehringer Mannheim Corp. | 1995-11-21 |
| FIRST CHOICE(TM) TEST STRIP (K946166) | Polymer Technology Intl. | 1995-11-08 |
| FIRST CHOICE TEST STRIP (K950628) | Polymer Technology Intl. | 1995-11-08 |
| EML105 ELECTROLYTE METABOLITE ANALYZER (K952621) | Radiometer America, Inc. | 1995-10-17 |
| WAKO AUTOKIT GLUCOSE (K950172) | Wako Chemicals USA, Inc. | 1995-10-05 |
| GLUCOMETER ELITE M BLOOD GLUCOSE METER (K951537) | Bayer Corp. | 1995-07-14 |
| ONE TOUCH II HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM (K950816) | Lifescan, Inc. | 1995-07-03 |
| PRECISION LINK BLOOD GLUCOSE DATA MANAGEMENT SYSTEM (K952279) | Medisense, Inc. | 1995-06-14 |
| ONE TOUCH PROFILE COMPLETE DIABETES TRACKING SYSTEM (K950727) | Lifescan, Inc. | 1995-06-01 |
| LIFESCAN SURESTEP BLOOD GLUCOSE MONITORING SYSTEM (K942455) | Lifescan, Inc. | 1995-03-24 |
| QUICKPRO BLOOD GLUCOSE TESTING SYSTEM (K944195) | Medisense, Inc. | 1995-03-23 |
| PRECISION Q I D BLOOD GLUCOSE TEST STRIPS (K945887) | Medisense, Inc. | 1995-03-23 |
| HEMOCUE B-GLUCOSE SYSTEM (K943432) | Hemocue, Inc. | 1995-01-17 |
| GLUCOCHEK (K940215) | Clinical Diagnostics, Inc. | 1995-01-17 |
| SIGMA GLUCOSE REAGENT (K933694) | Sigma Chemical Co. | 1994-11-04 |
| DMA GLUCOSE (OXIDASE) PROCEDURE (K943241) | Data Medical Associates, Inc. | 1994-10-20 |
| GLUCOFILM TEST STRIPS (K936212) | Heraeus Kulzer, Inc. | 1994-05-10 |
| RELIEF PLUS ONE REAGENT STRIP MODIFICATION (K934892) | Diagnostic Solutions, Inc. | 1994-01-11 |
| APEC GLUCOSE ANALYZER (K931196) | Apec, Inc. | 1993-12-07 |