Product code CGA— Clinical Chemistry
FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM
- Classification name
- Glucose Oxidase, Glucose
- Device class
- Class 2
- Regulation
- 21 CFR 862.1345
- Advisory panel
- Clinical Chemistry
- Total cleared
- 401
- First cleared
- Most recent
Clearances under product code CGA — page 2
101–200 of 401- K033055 — GLUCOSE REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMS
- K024014 — RANDOX RX DAYTONA
- K031472 — ONE TOUCH BASIC/PROFILE/ONE TOUCH II TEST STRIPS
- K031388 — MODIFICATION TO HYPOGUARD ADVANCE BLOOD GLUCOSE MONITORING SYSTEM
- K024347 — EXPRESS BLOOD GLUCOSE MONITORING SYSTEM
- K024062 — ASCENSIA BREEZE BLOOD GLUCOSE METER
- K023194 — SURESTEPPRO/SURESTEPFLEXX PROFESSIONAL BLOOD GLUCOSE MANAGEMENT SYSTEM
- K022580 — BACTON DICKINSON LATITUDE BLOOD GLUCOSE MONITORING SYSTEM
- K022158 — IQM (INTELLIGENT QUALITY MANAGEMENT) ON THE GEM PREMIER 3000, CVP (CALIBRATION VALIDATION PRODUCT)
- K021781 — EXCELSIOR 3UL TEST STRIPS, FOR USE WITH THE HOME DIAGNOSTICS, INC. PRESTIGE LX AND IQ BLOOD GLUCOSE SYSTEMS
- K021943 — ONETOUCH PROFILE BLOOD GLUCOSE MONITORING SYSTEM
- K020935 — HEMOCUE GLUCOSE 201 SYSTEM, ARTICLE NUMBER 120706
- K014139 — DIABETES ASSISTANT SOFTWARE
- K013342 — EXCELSIOR TEST STRIPS, FOR USE WITH THE HOME DIAGNOSTICS, INC.
- K020232 — HYPOGUARD ADVANCE BLOOD GLUCOSE MONITORING SYSTEM
- K011953 — WIENER LAB. GLICEMIA ENZIMATICA AA MODELS 1 X 250 ML CAT. #1400106; 4 250 ML CAT. # 1400107; WIENER LAB. GILICEMIA ENZCA
- K011479 — ONE TOUCH FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM, ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM
- K013068 — BIOSCANNER 2000
- K011233 — MODIFICATION TO GLUCOSURE BGM SYSTEM, MODEL 221100
- K010520 — GEM PREMIER 3000- ADDITION OF GLUCOSE AND LACTATE AS NEW PARAMETERS
- K010605 — ATLAST DATA MANAGEMENT SOFTWARE (DMS)
- K003346 — RANDOX GLUCOSE (GOD/PAP)
- K002688 — PERSONAL GLUCOSE CONTROL CHARTING SYSTEM
- K002621 — GLUCOSURE BLOOD GLUCOSE MONITORING SYSTEM
- K002624 — GLUCOSMART BLOOD GLUCOSE MONITORING SYSTEM
- K003257 — EHC400 DESKTOP PATIENT STATION; ECH600 CARE PROVIDER STATION
- K001441 — SATURN BLOOD GLUCOSE MONITORING TEST STRIP
- K001387 — I-STAT PORTABLE CLINICAL ANALYZER, MODEL 300
- K001907 — CAMIT DIABETES MANAGEMENT SOFTWARE
- K002134 — ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM
- K001092 — GENERIC BLOOD GLUCOSE TEST STRIP
- K001427 — MODIFICATION TO FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM
- K000583 — FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM
- K000365 — ACCU-CHEK ADVANTAGE METER
- K993837 — AVL OPTI CRITICAL CARE ANALYZER
- K993128 — HEALTHBUDDY WITH DEVICE CONNECT [GLUCOSE METER]
- K993632 — FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM
- K992988 — PRESTIGE LX BLOOD GLUCOSE TEST SYSTEM
- K991480 — EXCEL GE BLOOD GLUCOSE TEST STRIPS & CODE STRIP
- K991754 — GO GLUCOSE MONITORING SYSTEM
- K990942 — DUET II GLUCOSE CONTROL MONITORING SYSTEM
- K983504 — PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM, PRECISION BLOOD GLUCOSE TEST STRIPS, PRECISION XTRA B-KETONE TEST ST
- K990649 — GLUCOMETER ELITE XL BLOOD GLUCOSE METER, GLUCOMETER ELITE BLOOD GLUCOSE TEST SYSTEMS
- K991242 — GLUCOMETER ELITE TEST STRIPS
- K983344 — DADE BEHRING QUIKLYTE METABOLYTE CARTRIDGE, MODEL DIMENSION(R) XL OR RXL
- K984261 — SURESTEP BLOOD GLUCOSE MONITORING SYSTEM
- K984527 — IN TOUCH DIABETES MANAGEMENT SOFTWARE
- K990939 — FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM
- K984006 — GLUCOMETER ELITE XL BLOOD GLUCOSE METER
- K982076 — AMIRA MEDICAL ATLAST BLOOD GLUCOSE MONITORING SYSTEM
- K982303 — PRECISION PCX POINT OF CARE MANAGEMENT SYSTEM , QC MANAGER DATA MANAGER SYSTEM, PRECISION G PLUS BLOOD GLUCOSE TEST ST
- K980573 — SENSOREX BLOOD GLUCOSE MONITORING SYSTEM
- K981183 — CARESIDE GLUCOSE
- K974451 — ONE TOUCH II HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM
- K972669 — MTM BIOSCANNER 1000 TEST SYSTEM CONSISTING OF MTM BIOSCANNER 1000 METER, MTM BIOSCANNER G TEST STRIP, NORMAN GLUCOSE CON
- K971653 — GLUCOCHEK POCKETLAB II BLOOD GLUCOSE SYSTEM
- K972473 — ONE TOUCH II HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM DATA DOCK
- K973140 — DUET GLUCOSE CONTROL MONITORING SYSTEM
- K971145 — GLUCOSITE TEST SYSTEM
- K972733 — AVL OMNI ANALYZER
- K971812 — PRECISION QID BLOOD GLUCOSE TEST STRIP, PRECISION G BLOOD GLUCOSE TEST STRIP
- K970707 — ELECT II BLOOD GLUCOSE MONITORING SYSTEM
- K970556 — SURESTEP PRO BLOOD GLUCOSE MONITORING SYSTEM
- K970781 — LIQUID GLUCOSE (OXIDASE) REAGENT SET
- K963544 — SUPREME II METER
- K963676 — PRECISION G BLOOD GLUCOSE TESTING SYSTEM
- K964630 — GLUCOMETER ELITE BLOOD GLUCOSE METER
- K963500 — GLUCOMETER DEX DIABETES CARE SYSTEM
- K963535 — SIGMA DIAGNOSTICS GLUCOSE REAGENT
- K960855 — PRESTIGE BLOOD GLUCOSE MONITORING SYSTEM,METER,TEST STRIPS & PRESTIGE HIGH AND LOW GLUCOSE CONTROL
- K960337 — AMD HOME HEALTH MONITORING SYSTEM
- K961985 — ELECT BLOOD GLUCOSE MONITORIG SYSTEM
- K955107 — SAFESTRIP
- K962295 — PRECISION QID BLOOD GLUCOSE TEST STRIP
- K943503 — CHEMCARD GLUCOSE TEST
- K960034 — LXN BLOOD GLUCOSE TEST SYSTEM
- K960053 — SELFCARE BLOOD GLUCOSE TEST STRIPS FOR THE EXACTECH SYSTEM
- K961337 — EXACTECH RSG BLOOD GLUCOSE TESTING SYSTEM
- K955286 — EKTACHEM CLINICAL CHEMISTRY SLIDE GLUCOSE (GLU)
- K944459 — ACCU-CHEK INSTANT PLUS G-C/DM BLOOD GLUCOSE MONITORING SYSTEM
- K951457 — GLUCOCHEK POCKETLAB
- K952875 — ACCU-CHEK ALPHA MONITOR & ACCU-CHEK GLUCOSE TEST STRIPS
- K946166 — FIRST CHOICE(TM) TEST STRIP
- K950628 — FIRST CHOICE TEST STRIP
- K952621 — EML105 ELECTROLYTE METABOLITE ANALYZER
- K950172 — WAKO AUTOKIT GLUCOSE
- K951537 — GLUCOMETER ELITE M BLOOD GLUCOSE METER
- K950816 — ONE TOUCH II HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM
- K952279 — PRECISION LINK BLOOD GLUCOSE DATA MANAGEMENT SYSTEM
- K950727 — ONE TOUCH PROFILE COMPLETE DIABETES TRACKING SYSTEM
- K942455 — LIFESCAN SURESTEP BLOOD GLUCOSE MONITORING SYSTEM
- K944195 — QUICKPRO BLOOD GLUCOSE TESTING SYSTEM
- K945887 — PRECISION Q I D BLOOD GLUCOSE TEST STRIPS
- K940215 — GLUCOCHEK
- K943432 — HEMOCUE B-GLUCOSE SYSTEM
- K933694 — SIGMA GLUCOSE REAGENT
- K943241 — DMA GLUCOSE (OXIDASE) PROCEDURE
- K936212 — GLUCOFILM TEST STRIPS
- K934892 — RELIEF PLUS ONE REAGENT STRIP MODIFICATION
- K931196 — APEC GLUCOSE ANALYZER
Data sourced from openFDA. This site is unofficial and independent of the FDA.