CGA
FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM
- Advisory panel
- Clinical Chemistry
- Total cleared
- 400
Adverse events under product code CGA
product code CGA- Death
- 2
- Malfunction
- 1,816
- Total
- 1,818
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code CGA
1–100 of 400- K210933 — YSI 2900C Biochemistry Analyzer
- K220328 — EasyStat 300
- K223179 — Cholestech LDX System
- K223755 — i-STAT G cartridge with the i-STAT 1 System
- K223710 — i-STAT CG8+ cartridge with the i-STAT 1 System
- K223090 — GEM Premier ChemSTAT
- K203549 — Nova Primary Glucose Analyzer System
- K210958 — i-STAT CHEM8+ cartridge with the i-STAT 1 System
- K200349 — Stat Profile Prime Plus Analyzer System
- K183678 — i-STAT CHEM8+ cartridge with the i-STAT 1 System
- K190520 — VITROS XT Chemistry Products GLU-Ca Slides
- K183546 — GEM Premier ChemSTAT
- K182781 — PTS Professional Chemistry Kit
- K180340 — Stat Profile Prime Plus Analyzer System
- K163433 — VITROS Chemistry Products GLU Slides
- K163271 — i-Stat Alinity System with i-Stat Glucose test
- K162282 — CardioChek Plus Test System, CardioChek Home Test System
- K160402 — GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin)
- K161818 — GEM Premier 3000
- K153692 — Synermed Glucose Reagent, Synermed IR-1200 Chemistry Analyzer
- K151639 — ABL80 FLEX and ABL80 FLEX CO-OX
- K142689 — GAL-1F Blood Glucose Monitoring System, GAL-1F Pro Blood Glucose Monitoring System
- K151530 — CardioChek Plus Test System
- K143750 — MEG-2B Blood Glucose Monitoring System, MEG-2B Pro Blood Glucose Monitoring System
- K142302 — BioScanner Plus Glucose Test System, PTS PANELS Chol+Glu Test Panel System, PTS PANELS Lipid Panel Test System, PTS PANELS HDL Cholesterol Test System, PTS PANELS CHOL+HDL Test System, PTS PANELS CHOL+HDL+GLU Panel Test System, PTS PANELS Metabolic Chemistry Panel Test System
- K142336 — GLUCOCARD 01 Blood Glocose Monitoring System/ReliOn Confirm Blood Glucose Monitoring System
- K133584 — IN TOUCH BLOOD GLUCOSE MONITORING SYSTEM
- K124021 — ARKRAY GLUCOCARD 01 BLOOD GLUCOSE MONITORING SYSTEM AND RELION CONFIRM BLOOD GLUCOSE MONITORING SYSTEM
- K131750 — AUTOSURE HT BLOOD GLUCOSE MONITORING SYSTEM
- K120615 — ALERE CHOLESTECH LDX ANALYZER, ALERE CHOLESTECH LDX LIPID PROFILE - GLU CASSETTE
- K113636 — BLOOD GLUCOSE MONITORING SYSTEM (GLUCOSE OXIDASE)
- K121706 — FORA V10 BLOOD GLUCOSE MONITORING SYSTEM
- K122110 — ACON ON CALL VIVID PAL BLOOD GLUCOSE MONITORING SYSTEM
- K121654 — AUTO-CHEK BLOOD GLUCOSE MONITORING SYSTEM, METER, TEST STRIP. AUTO-CHECK CONTROL SOLUTION
- K120921 — CLEVER CHOICE
- K120759 — CARESENS N MINI BLOOD GLUCOSE MONITORING SYSTEM, MINI BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST STRIP, CONTROL SOLUTION
- K113670 — ELEMENT BLOOD GLUCOSE MONITORING SYSTEM
- K103230 — AP-3000 BLOOD GLUCOSE MONITORING SYSTEM, MAJOR GLUCOSE CONTROL SOLUTION
- K120448 — MEG-2B BLOOD GLUCOSE MONITORING SYSTEM, PRO BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE TEST STRIPS, GLUCOSE CONTROL
- K113547 — GAL-1E BLOOD GLUCOSE MONITORING SYSTEM GAL-1E BLOOD GLUCOSE TEST STRIPS GAL-1E MULTI BLOOD GLUCOSE MONITORING SYSTEM GAL
- K103116 — AP-2000, AP-2010, AND AP-2020 BLOOD GLUCOSE MONITORING SYSTEM
- K113208 — GAL-1A BLOOD GLUCOSE MONITORING SYSTEM
- K103278 — ACURA PLUS BLOOD GLUCOSE MONITORING SYSTEM; ACURA PLUS BLOOD GLUCOSE METER; ACURA CONTROL SOLUTION
- K102316 — GLUCOSE SHEPHERD BLOOD GLUCOSE MONITORING SYSTEM
- K111371 — ON CALL CHOSEN BLOOD GLUCOSE MONITORING SYSTEM
- K111728 — EMV3 SELF MONITORING BLOOD GLUCOSE SYSTEM, EMV3 PRO SELF MONITORING BLOOD GLUCOSE SYSTEM
- K101204 — MEG-2 BLOOD GLUCOSE MONITORING SYSTEM, MEG-2 50'S TEST STRIP, MEG-2 CONTROL SOLUTION
- K103842 — UNICEL DXC 600 SYNCHRON SYSTEM SOFTWARE VERSION 5.0 AND UNICEL DXC 800 SYNCHRON SYSTEM SOFTWARE VERSION 5.0
- K101947 — IVD-GE02
- K103195 — I-STAT 1 WIRELESS ANALYZER
- K101741 — DIATRON PICTUS 400
- K100525 — ELITECH CLINICAL SYSTEMS GLUCOSE PAP SL ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL 1 AND 2
- K102037 — AUTOSURE VOICE II BLOOD GLUCOSE MONITORING SYSTEM AND TEST STRIPS
- K100405 — FORA G90 PERFORM BLOOD GLUCOSE MONITORING SYSTEM
- K100406 — FORA V20 BLOOD GLUCOSE MONITORING SYSTEM
- K100187 — EASYRA GLU-T REAGENT, EASYRA GLU-H REAGENT
- K093506 — CLEVER CHOICE AUTO-CODE PRO BLOOD GLUCOSE MONITORING SYSTEM MODEL TD-4267
- K093941 — CLEVER CHOICE MINI BLOOD GLUCOSE MONITORING SYSTEM MODEL TD-4265
- K091975 — INTEGRATED LABORATORY AUTOMATION SOLUTION
- K082965 — DS-A BLOOD GLUCOSE MONITORING SYSTEM
- K092104 — ASSURE PLATINUM BLOOD GLUCOSE MONITORING SYSTEM
- K091814 — FORA D20 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM; TD-3263 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTE
- K091102 — ASSURE PLATINUM AND GLUCOCARD VITAL BLOOD GLUCOSE MONITORING SYSTEMS
- K090109 — BLOOD GAS, ELECTROLYTE AND METABOLITE TEST CARD
- K090043 — AUTOSURE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90011F9
- K083570 — U-RIGHT TD-4249/U-RIGHT TD-4250 BLOOD GLUCOSE MONITORING SYSTEM
- K080636 — DUO-MAX BLOOD PRESSURE & GLUCOSE MONITOR HMF-100
- K082482 — FORA TD-4251/U-RIGHT TD-4252/U-RIGHT TD-4254 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4251/TD-4252A/TD-4252B/TD-4254
- K083664 — FORA TD-4245 BLOOD GLUCOSE MONITORING SYSTEM, TD-4245
- K082417 — GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, MODEL 73110
- K082121 — EASYMAX SELF MONITORING GLUCOSE TEST SYSTEM, MODEL # EPS08005
- K081714 — FORA TD-3224 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM
- K081609 — CLEVER CHEK AND AUDIOCHEK BLOOD GLUCOSE MONITORING SYSTEMS, MODEL TD-4237
- K073416 — ARKRAY GLUCOCARD 01 BLOOD MONITORING SYSTEM
- K073648 — GLUCOSURE STAR BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90000E1
- K070057 — EASYRA CLINICAL CHEMISTRY ANALYZER
- K070704 — TRILOGY ANALYZER
- K070960 — NOVA STATSTRIP XPRESS GLUCOSE HOSPITAL METER SYSTEM
- K062799 — GLUCO TRACK BLOOD GLUCOSE MONITORING SYSTEM
- K063821 — NOVA STATSTRIP GLUCOSE HOSPITAL METER SYSTEM
- K062892 — EUKARE
- K061431 — EASYGLUCO, MODEL IGM-0002 G2
- K061528 — SELFCHECK GLUCO
- K061992 — EASYPLUS SELF MONITORING GLUCOSE TEST SYSTEM, MODEL EPS04014
- K060345 — NOVA STATSTRIP GLUCOSE HOSPITAL METER, STATSTRIP CONTROL SOLUTIONS
- K053079 — ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 460001
- K052207 — ACCUREX GLUCOSE TEST STRIP
- K052121 — GEM PREMIER 3000
- K050182 — Q.STEPS BIOMETER G/C DUAL MONITORING SYSTEM
- K051285 — GLUCOLAB BLOOD GLUCOSE MONITORING SYSTEM
- K043197 — ONETOUCH ULTRA, INDUO AND ULTRASMART BLOOD GLUCOSE MONITORING SYSTEM
- K043245 — EPS EASY PAIN SUPREME SELF MONITORING BLOOD GLUCOSE SYSTEM
- K043512 — EASYGLUCO IGM-0002 G2
- K041881 — ADVANCE MICRO-DRAW BLOOD GLUCOSE MONITORING SYSTEM, MODEL 411100
- K040974 — GLUCOSE OXIDASE, GLUCOSE
- K041427 — THE POLYMEDCO SPOTCHEM EX GLUCOSE, FRUCTOSAMINE AND AST TESTS
- K041478 — BD LOGIC BLOOD GLUCOSE MONITOR AND PARADIGM LINK BLOOD GLUCOSE MONITOR
- K042015 — ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA CHEMISTRY GLUCOSE HEXOKINASE
- K033627 — Q.STEPS BIOMETER G BLOOD GLUCOSE MONITORING SYSTEM
- K033055 — GLUCOSE REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMS
Data sourced from openFDA. This site is unofficial and independent of the FDA.