FDA Product Code
FDA Product Code CGA — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1345
510(k) Clearances — 401 records · page 2 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K033055 | GLUCOSE REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMS | Diamond Diagnostics, Inc. | 2004-01-30 | Traditional | PDF ↗ |
| K024014 | RANDOX RX DAYTONA | Randox Laboratories, Ltd. | 2003-12-04 | Traditional | PDF ↗ |
| K031472 | ONE TOUCH BASIC/PROFILE/ONE TOUCH II TEST STRIPS | Lifescan, Inc. | 2003-08-05 | Traditional | PDF ↗ |
| K031388 | MODIFICATION TO HYPOGUARD ADVANCE BLOOD GLUCOSE MONITORING SYSTEM | Hypoguard USA, Inc. | 2003-05-22 | Special | PDF ↗ |
| K024347 | EXPRESS BLOOD GLUCOSE MONITORING SYSTEM | Hypoguard USA, Inc. | 2003-03-28 | Traditional | PDF ↗ |
| K024062 | ASCENSIA BREEZE BLOOD GLUCOSE METER | Bayer Corp. | 2003-03-03 | Traditional | PDF ↗ |
| K023194 | SURESTEPPRO/SURESTEPFLEXX PROFESSIONAL BLOOD GLUCOSE MANAGEMENT SYSTEM | Lifescan, Inc. | 2002-10-24 | Special | PDF ↗ |
| K022580 | BACTON DICKINSON LATITUDE BLOOD GLUCOSE MONITORING SYSTEM | Becton, Dickinson & CO | 2002-10-09 | Traditional | PDF ↗ |
| K022158 | IQM (INTELLIGENT QUALITY MANAGEMENT) ON THE GEM PREMIER 3000, CVP (CALIBRATION VALIDATION PRODUCT) | Instrumentation Laboratory CO | 2002-09-10 | Traditional | PDF ↗ |
| K021781 | EXCELSIOR 3UL TEST STRIPS, FOR USE WITH THE HOME DIAGNOSTICS, INC. PRESTIGE LX AND IQ BLOOD GLUCOSE SYSTEMS | Chay Medical, LLC | 2002-08-30 | Traditional | PDF ↗ |
| K021943 | ONETOUCH PROFILE BLOOD GLUCOSE MONITORING SYSTEM | Lifescan, Inc. | 2002-06-28 | Traditional | PDF ↗ |
| K020935 | HEMOCUE GLUCOSE 201 SYSTEM, ARTICLE NUMBER 120706 | Hemocue, Inc. | 2002-04-03 | Special | PDF ↗ |
| K014139 | DIABETES ASSISTANT SOFTWARE | Roche Diagnostics Corp. | 2002-03-21 | Special | PDF ↗ |
| K013342 | EXCELSIOR TEST STRIPS, FOR USE WITH THE HOME DIAGNOSTICS, INC. | Chay Medical, LLC | 2002-02-15 | Traditional | PDF ↗ |
| K020232 | HYPOGUARD ADVANCE BLOOD GLUCOSE MONITORING SYSTEM | Hypoguard USA, Inc. | 2002-02-12 | Traditional | PDF ↗ |
| K011953 | WIENER LAB. GLICEMIA ENZIMATICA AA MODELS 1 X 250 ML CAT. #1400106; 4 250 ML CAT. # 1400107; WIENER LAB. GILICEMIA ENZCA | Wiener Laboratories Saic | 2001-12-21 | Traditional | PDF ↗ |
| K011479 | ONE TOUCH FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM, ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM | Inverness Medical Innovations, Inc. | 2001-11-30 | Traditional | PDF ↗ |
| K013068 | BIOSCANNER 2000 | Polymer Technology Systems, Inc. | 2001-11-20 | Traditional | PDF ↗ |
| K011233 | MODIFICATION TO GLUCOSURE BGM SYSTEM, MODEL 221100 | Apex BioTechnology Corp. | 2001-05-18 | Special | PDF ↗ |
| K010520 | GEM PREMIER 3000- ADDITION OF GLUCOSE AND LACTATE AS NEW PARAMETERS | Instrumentation Laboratory CO | 2001-05-07 | Traditional | PDF ↗ |
| K010605 | ATLAST DATA MANAGEMENT SOFTWARE (DMS) | Amira Medical, Inc. | 2001-05-07 | Traditional | PDF ↗ |
| K003346 | RANDOX GLUCOSE (GOD/PAP) | Randox Laboratories, Ltd. | 2001-03-15 | Traditional | PDF ↗ |
| K002688 | PERSONAL GLUCOSE CONTROL CHARTING SYSTEM | Lxn Corp. | 2001-02-01 | Traditional | PDF ↗ |
| K002621 | GLUCOSURE BLOOD GLUCOSE MONITORING SYSTEM | Apex BioTechnology Corp. | 2001-01-22 | Traditional | PDF ↗ |
| K002624 | GLUCOSMART BLOOD GLUCOSE MONITORING SYSTEM | Apex BioTechnology Corp. | 2001-01-22 | Traditional | PDF ↗ |
| K003257 | EHC400 DESKTOP PATIENT STATION; ECH600 CARE PROVIDER STATION | Cybercare Technologies, Inc. | 2000-12-22 | Traditional | PDF ↗ |
| K001441 | SATURN BLOOD GLUCOSE MONITORING TEST STRIP | Lifescan, Inc. | 2000-12-18 | Traditional | PDF ↗ |
| K001387 | I-STAT PORTABLE CLINICAL ANALYZER, MODEL 300 | I-Stat Corp. | 2000-10-05 | Traditional | PDF ↗ |
| K001907 | CAMIT DIABETES MANAGEMENT SOFTWARE | Roche Diagnostics Corp. | 2000-09-05 | Traditional | PDF ↗ |
| K002134 | ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM | Selfcare, Inc. | 2000-08-07 | Special | PDF ↗ |
| K001092 | GENERIC BLOOD GLUCOSE TEST STRIP | Inbios Intl., Inc. | 2000-07-26 | Traditional | PDF ↗ |
| K001427 | MODIFICATION TO FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM | Selfcare, Inc. | 2000-06-02 | Special | PDF ↗ |
| K000583 | FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM | Selfcare, Inc. | 2000-03-17 | Special | PDF ↗ |
| K000365 | ACCU-CHEK ADVANTAGE METER | Roche Diagnostics Corp. | 2000-02-23 | Special | PDF ↗ |
| K993837 | AVL OPTI CRITICAL CARE ANALYZER | Avl Scientific Corp. | 1999-12-16 | Traditional | PDF ↗ |
| K993128 | HEALTHBUDDY WITH DEVICE CONNECT [GLUCOSE METER] | Health Hero Network, Inc. | 1999-11-23 | Traditional | PDF ↗ |
| K993632 | FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM | Selfcare, Inc. | 1999-11-12 | Special | PDF ↗ |
| K992988 | PRESTIGE LX BLOOD GLUCOSE TEST SYSTEM | Home Diagnostics, Inc. | 1999-09-24 | Special | PDF ↗ |
| K991480 | EXCEL GE BLOOD GLUCOSE TEST STRIPS & CODE STRIP | Selfcare, Inc. | 1999-09-17 | Traditional | PDF ↗ |
| K991754 | GO GLUCOSE MONITORING SYSTEM | Lxn Corp. | 1999-09-08 | Traditional | PDF ↗ |
| K990942 | DUET II GLUCOSE CONTROL MONITORING SYSTEM | Lxn Corp. | 1999-08-02 | Traditional | PDF ↗ |
| K983504 | PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM, PRECISION BLOOD GLUCOSE TEST STRIPS, PRECISION XTRA B-KETONE TEST ST | Medisense, Inc. | 1999-07-09 | Traditional | PDF ↗ |
| K990649 | GLUCOMETER ELITE XL BLOOD GLUCOSE METER, GLUCOMETER ELITE BLOOD GLUCOSE TEST SYSTEMS | Bayer Corp. | 1999-07-09 | Traditional | PDF ↗ |
| K991242 | GLUCOMETER ELITE TEST STRIPS | Bayer Corp. | 1999-06-30 | Traditional | PDF ↗ |
| K983344 | DADE BEHRING QUIKLYTE METABOLYTE CARTRIDGE, MODEL DIMENSION(R) XL OR RXL | Dade Behring, Inc. | 1999-06-22 | Traditional | PDF ↗ |
| K984261 | SURESTEP BLOOD GLUCOSE MONITORING SYSTEM | Lifescan, Inc. | 1999-05-21 | Traditional | PDF ↗ |
| K984527 | IN TOUCH DIABETES MANAGEMENT SOFTWARE | Lifescan, Inc. | 1999-04-29 | Traditional | PDF ↗ |
| K990939 | FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM | Selfcare, Inc. | 1999-04-20 | Special | PDF ↗ |
| K984006 | GLUCOMETER ELITE XL BLOOD GLUCOSE METER | Bayer Corp. | 1999-03-18 | Traditional | PDF ↗ |
| K982076 | AMIRA MEDICAL ATLAST BLOOD GLUCOSE MONITORING SYSTEM | Amira Medical, Inc. | 1998-12-10 | Traditional | PDF ↗ |
| K982303 | PRECISION PCX POINT OF CARE MANAGEMENT SYSTEM , QC MANAGER DATA MANAGER SYSTEM, PRECISION G PLUS BLOOD GLUCOSE TEST ST | Medisense, Inc. | 1998-12-08 | Traditional | PDF ↗ |
| K980573 | SENSOREX BLOOD GLUCOSE MONITORING SYSTEM | Chronimed, Inc. | 1998-07-30 | Traditional | PDF ↗ |
| K981183 | CARESIDE GLUCOSE | Exigent Diagnostics, Inc. | 1998-05-07 | Traditional | PDF ↗ |
| K974451 | ONE TOUCH II HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM | Lifescan, Inc. | 1998-01-26 | Traditional | PDF ↗ |
| K972669 | MTM BIOSCANNER 1000 TEST SYSTEM CONSISTING OF MTM BIOSCANNER 1000 METER, MTM BIOSCANNER G TEST STRIP, NORMAN GLUCOSE CON | Polymer Technology Systems, Inc. | 1998-01-22 | Traditional | PDF ↗ |
| K971653 | GLUCOCHEK POCKETLAB II BLOOD GLUCOSE SYSTEM | Clinical Diagnostics, Inc. | 1998-01-02 | Traditional | PDF ↗ |
| K972473 | ONE TOUCH II HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM DATA DOCK | Lifescan, Inc. | 1997-12-16 | Traditional | PDF ↗ |
| K973140 | DUET GLUCOSE CONTROL MONITORING SYSTEM | Lxn Corp. | 1997-10-31 | Traditional | PDF ↗ |
| K971145 | GLUCOSITE TEST SYSTEM | Gds Technology, LLC | 1997-09-17 | Traditional | PDF ↗ |
| K972733 | AVL OMNI ANALYZER | Avl Scientific Corp. | 1997-09-09 | Traditional | PDF ↗ |
| K971812 | PRECISION QID BLOOD GLUCOSE TEST STRIP, PRECISION G BLOOD GLUCOSE TEST STRIP | Medisense, Inc. | 1997-08-08 | Traditional | PDF ↗ |
| K970707 | ELECT II BLOOD GLUCOSE MONITORING SYSTEM | Selfcare, Inc. | 1997-06-20 | Traditional | PDF ↗ |
| K970556 | SURESTEP PRO BLOOD GLUCOSE MONITORING SYSTEM | Lifescan, Inc. | 1997-05-12 | Traditional | PDF ↗ |
| K970781 | LIQUID GLUCOSE (OXIDASE) REAGENT SET | Pointe Scientific, Inc., | 1997-04-21 | Traditional | PDF ↗ |
| K963676 | PRECISION G BLOOD GLUCOSE TESTING SYSTEM | Medisense, Inc. | 1997-02-20 | Traditional | PDF ↗ |
| K963544 | SUPREME II METER | Chronimed, Inc. | 1997-02-20 | Traditional | PDF ↗ |
| K964630 | GLUCOMETER ELITE BLOOD GLUCOSE METER | Bayer Corp. | 1997-02-10 | Traditional | PDF ↗ |
| K963500 | GLUCOMETER DEX DIABETES CARE SYSTEM | Bayer Corp. | 1997-01-21 | Traditional | PDF ↗ |
| K963535 | SIGMA DIAGNOSTICS GLUCOSE REAGENT | Sigma Diagnostics, Inc. | 1997-01-17 | Traditional | PDF ↗ |
| K960855 | PRESTIGE BLOOD GLUCOSE MONITORING SYSTEM,METER,TEST STRIPS & PRESTIGE HIGH AND LOW GLUCOSE CONTROL | Home Diagnostics, Inc. | 1996-11-07 | Traditional | PDF ↗ |
| K960337 | AMD HOME HEALTH MONITORING SYSTEM | Advanced Medical Devices, Inc. | 1996-09-24 | Traditional | PDF ↗ |
| K961985 | ELECT BLOOD GLUCOSE MONITORIG SYSTEM | Selfcare, Inc. | 1996-09-05 | Traditional | PDF ↗ |
| K955107 | SAFESTRIP | Firehouse Medical, Inc. | 1996-08-16 | Traditional | PDF ↗ |
| K962295 | PRECISION QID BLOOD GLUCOSE TEST STRIP | Medisense, Inc. | 1996-07-26 | Traditional | PDF ↗ |
| K943503 | CHEMCARD GLUCOSE TEST | Chem-Elec, Inc. | 1996-07-23 | Traditional | PDF ↗ |
| K960034 | LXN BLOOD GLUCOSE TEST SYSTEM | Lxn Corp. | 1996-06-28 | Traditional | PDF ↗ |
| K960053 | SELFCARE BLOOD GLUCOSE TEST STRIPS FOR THE EXACTECH SYSTEM | Selfcare, Inc. | 1996-06-28 | Traditional | PDF ↗ |
| K961337 | EXACTECH RSG BLOOD GLUCOSE TESTING SYSTEM | Medisense, Inc. | 1996-06-21 | Traditional | PDF ↗ |
| K955286 | EKTACHEM CLINICAL CHEMISTRY SLIDE GLUCOSE (GLU) | Johnson & Johnson Clinical Diagnostics, Inc. | 1996-05-17 | Traditional | PDF ↗ |
| K944459 | ACCU-CHEK INSTANT PLUS G-C/DM BLOOD GLUCOSE MONITORING SYSTEM | Boehringer Mannheim Corp. | 1996-04-17 | Traditional | PDF ↗ |
| K951457 | GLUCOCHEK POCKETLAB | Clinical Diagnostics, Inc. | 1996-02-22 | Traditional | PDF ↗ |
| K952875 | ACCU-CHEK ALPHA MONITOR & ACCU-CHEK GLUCOSE TEST STRIPS | Boehringer Mannheim Corp. | 1995-11-21 | Traditional | PDF ↗ |
| K950628 | FIRST CHOICE TEST STRIP | Polymer Technology Intl. | 1995-11-08 | Traditional | PDF ↗ |
| K946166 | FIRST CHOICE(TM) TEST STRIP | Polymer Technology Intl. | 1995-11-08 | Traditional | PDF ↗ |
| K952621 | EML105 ELECTROLYTE METABOLITE ANALYZER | Radiometer America, Inc. | 1995-10-17 | Traditional | PDF ↗ |
| K950172 | WAKO AUTOKIT GLUCOSE | Wako Chemicals USA, Inc. | 1995-10-05 | Traditional | PDF ↗ |
| K951537 | GLUCOMETER ELITE M BLOOD GLUCOSE METER | Bayer Corp. | 1995-07-14 | Traditional | PDF ↗ |
| K950816 | ONE TOUCH II HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM | Lifescan, Inc. | 1995-07-03 | Traditional | PDF ↗ |
| K952279 | PRECISION LINK BLOOD GLUCOSE DATA MANAGEMENT SYSTEM | Medisense, Inc. | 1995-06-14 | Traditional | PDF ↗ |
| K950727 | ONE TOUCH PROFILE COMPLETE DIABETES TRACKING SYSTEM | Lifescan, Inc. | 1995-06-01 | Traditional | PDF ↗ |
| K942455 | LIFESCAN SURESTEP BLOOD GLUCOSE MONITORING SYSTEM | Lifescan, Inc. | 1995-03-24 | Traditional | PDF ↗ |
| K944195 | QUICKPRO BLOOD GLUCOSE TESTING SYSTEM | Medisense, Inc. | 1995-03-23 | Traditional | PDF ↗ |
| K945887 | PRECISION Q I D BLOOD GLUCOSE TEST STRIPS | Medisense, Inc. | 1995-03-23 | Traditional | PDF ↗ |
| K943432 | HEMOCUE B-GLUCOSE SYSTEM | Hemocue, Inc. | 1995-01-17 | Traditional | PDF ↗ |
| K940215 | GLUCOCHEK | Clinical Diagnostics, Inc. | 1995-01-17 | Traditional | PDF ↗ |
| K933694 | SIGMA GLUCOSE REAGENT | Sigma Chemical Co. | 1994-11-04 | Traditional | PDF ↗ |
| K943241 | DMA GLUCOSE (OXIDASE) PROCEDURE | Data Medical Associates, Inc. | 1994-10-20 | Traditional | PDF ↗ |
| K936212 | GLUCOFILM TEST STRIPS | Heraeus Kulzer, Inc. | 1994-05-10 | Traditional | PDF ↗ |
| K934892 | RELIEF PLUS ONE REAGENT STRIP MODIFICATION | Diagnostic Solutions, Inc. | 1994-01-11 | Traditional | PDF ↗ |
| K934898 | GLUCOMETER QA BLOOD GLUCOSE METER MODIFICATION | Heraeus Kulzer, Inc. | 1993-12-07 | Traditional | PDF ↗ |
Product code CGA · Class II · Clinical Chemistry. Data: openFDA.