Product Code: NBW


Products Classified as NBW

630System, Test, Blood Glucose, Over The CounterGlucose Test System.

Total Product Life Cycle (TPLC) Devices

630System, Test, Blood Glucose, Over The CounterGlucose Test System.

FDA Consensus Standards

System, Test, Blood Glucose, Over The Counter [32368]21 CFR §862.1345 🔎
System, Test, Blood Glucose, Over The Counter [35909]21 CFR §862.1345 🔎
System, Test, Blood Glucose, Over The Counter [35812]21 CFR §862.1345 🔎

Pre-market Notifications for NBW

K223293CONTOUR® NEXT GEN Blood Glucose Monitoring SystemAscensia Diabetes Care US Inc.
K220421BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring SystemApex BioTechnology Corp.
K213887GAL-1A Plus Blood Glucose Monitoring SystemApex BioTechnology Corp.
K213061SuperCheck Pro Blood Glucose Monitoring SystemOK BioTech Co., Ltd.
K212140GlucoSure Link Blood Glucose Monitoring SystemApex Biotechnology Corp.
K210687CONTOUR® NEXT ONE Blood Glucose Monitoring SystemAscensia Diabetes Care
K203711IWL2020 Blood Glucose Monitoring SystemRoche Diabetes Care Inc.
K202885GlucoSure HT Plus Blood Glucose Monitoring SystemApex BioTechnology Corp.
K202739Bioland G-425-2V Blood Glucose Monitoring System, Bioland G-425-2 Blood Glucose Monitoring SystemBioland Technology Ltd.
K202534MTM301 Blood Glucose And Ketone Monitoring SystemApex Biotechnology Corp.
K201880MultiSure GK Link Blood Glucose And Ketone Monitoring SystemApex Biotechnology Corp.
K201396Finetest Lite Smart Blood Glucose Monitoring SystemOSANG Healthcare Co., Ltd.
K201394CareSens N Feliz Blood Glucose Monitoring System, CareSens N Feliz BT Blood Glucose Monitoring SystemI-SENS, Inc.
K201258EASYMAX Tag Self-Monitoring Blood Glucose SystemEPS Bio Technology Corp.
K201037FORA ADVANCED GD40 Glucose, ß-Ketone And Cholesterol Monitoring SystemTaiDoc Technology Corporation

Global Unique Device Identification Database

10605388860160SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
10605388860153SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
10605388492286SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
10605388022933SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
10605388022926SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
00389167348508System, Test, Blood Glucose, Over The Counter
00389154000709System, Test, Blood Glucose, Over The Counter
20385544940017System, Test, Blood Glucose, Over The Counter
00385544025017System, Test, Blood Glucose, Over The Counter
20385542649011System, Test, Blood Glucose, Over The Counter
10385541002605System, Test, Blood Glucose, Over The Counter
00385541002509System, Test, Blood Glucose, Over The Counter
10385541002407System, Test, Blood Glucose, Over The Counter
10385541002001System, Test, Blood Glucose, Over The Counter
20385541000806System, Test, Blood Glucose, Over The Counter

Maude Adverse Events

TRUE METRIXTRIVIDIA HEALTH INC2020-03-31
TRUE METRIXTRIVIDIA HEALTH INC2020-03-31
TRUE METRIXTRIVIDIA HEALTH INC2020-03-31
TRUE METRIXTRIVIDIA HEALTH INC2020-03-31
TRUE METRIXTRIVIDIA HEALTH INC2020-03-31
TRUE METRIXTRIVIDIA HEALTH INC2020-03-31
ACCU-CHEK ? GUIDE TEST STRIPSROCHE DIABETES CARE, INC.2020-03-31
ACCU-CHEK ? AVIVA PLUS TEST STRIPSROCHE DIABETES CARE, INC.2020-03-31
ACCU-CHEK ? GUIDE TEST STRIPSROCHE DIABETES CARE, INC.2020-03-31
ACCU-CHEK ? AVIVA PLUS TEST STRIPSROCHE DIABETES CARE, INC.2020-03-31
ACCU-CHEK ? AVIVA PLUS TEST STRIPSROCHE DIABETES CARE, INC.2020-03-31
ACCU-CHEK ? SMARTVIEW TEST STRIPSROCHE DIABETES CARE, INC.2020-03-31
ACCU-CHEK ? GUIDE TEST STRIPSROCHE DIABETES CARE, INC.2020-03-31
ACCU-CHEK ? AVIVA TEST STRIPSROCHE DIABETES CARE, INC.2020-03-31
ACCU-CHEK ? PERFORMA COMBOROCHE DIABETES CARE, INC.2020-03-31
ACCU-CHEK ? PERFORMA COMBOROCHE DIABETES CARE, INC.2020-03-31
ACCU-CHEK ? PERFORMA TEST STRIPSROCHE DIABETES CARE, INC.2020-03-31
ACCU-CHEK ? AVIVA PLUS TEST STRIPSROCHE DIABETES CARE, INC.2020-03-31
ACCU-CHEK ? PERFORMA COMBOROCHE DIABETES CARE, INC.2020-03-31
ACCU-CHEK ? AVIVA PLUS TEST STRIPSROCHE DIABETES CARE, INC.2020-03-31
ACCU-CHEK ? AVIVA PLUS TEST STRIPSROCHE DIABETES CARE, INC.2020-03-31
ACCU-CHEK ? PERFORMA COMBOROCHE DIABETES CARE, INC.2020-03-31
OT VERIO IQ METERLIFESCAN EUROPE GMBH2020-03-31
OT VERIO IQ METERLIFESCAN EUROPE GMBH2020-03-31
ACCU-CHEK ? PERFORMA TEST STRIPSROCHE DIABETES CARE, INC.2020-03-31
ACCU-CHEK ? AVIVA COMBOROCHE DIABETES CARE, INC.2020-03-31
ACCU-CHEK ? AVIVA TEST STRIPSROCHE DIABETES CARE, INC.2020-03-31
ACCU-CHEK ? AVIVA TEST STRIPSROCHE DIABETES CARE, INC.2020-03-31
ACCU-CHEK ? GUIDE TEST STRIPSROCHE DIABETES CARE, INC.2020-03-31
ACCU-CHEK ? AVIVA COMBOROCHE DIABETES CARE, INC.2020-03-31
ACCU-CHEK ? GUIDE TEST STRIPSROCHE DIABETES CARE, INC.2020-03-31
ACCU-CHEK ? GUIDE TEST STRIPSROCHE DIABETES CARE, INC.2020-03-31
PRODIGY AUTO CODEOK BIOTECH COMPANY LTD2020-03-31
ACCU-CHEK ? PERFORMA TEST STRIPSROCHE DIABETES CARE, INC.2020-03-30
ACCU-CHEK ? PERFORMA COMBOROCHE DIABETES CARE, INC.2020-03-30
ACCU-CHEK ? AVIVA COMBOROCHE DIABETES CARE, INC.2020-03-30
ACCU-CHEK ? AVIVA EXPERTROCHE DIABETES CARE, INC.2020-03-30
ACCU-CHEK ? NANOROCHE DIABETES CARE, INC.2020-03-30
ACCU-CHEK ? PERFORMA TEST STRIPSROCHE DIABETES CARE, INC.2020-03-30
OT VERIO FLEX METERLIFESCAN EUROPE GMBH2020-03-30
OT VERIO FLEX METERLIFESCAN EUROPE GMBH2020-03-30
PRODIGY AUTO CODEOK BIOTECH COMPANY LTD2020-03-29
ACCU-CHEK ? GUIDE TEST STRIPSROCHE DIABETES CARE, INC.2020-03-28
ACCU-CHEK ? AVIVA PLUS TEST STRIPSROCHE DIABETES CARE, INC.2020-03-28
ACCU-CHEK ? PERFORMA TEST STRIPSROCHE DIABETES CARE, INC.2020-03-28
ACCU-CHEK ? SMARTVIEW TEST STRIPSROCHE DIABETES CARE, INC.2020-03-28
ACCU-CHEK ? GUIDE TEST STRIPSROCHE DIABETES CARE, INC.2020-03-28
ACCU-CHEK ? PERFORMA TEST STRIPSROCHE DIABETES CARE, INC.2020-03-28
ACCU-CHEK ? AVIVA PLUS TEST STRIPSROCHE DIABETES CARE, INC.2020-03-28
ACCU-CHEK ? AVIVA PLUS TEST STRIPSROCHE DIABETES CARE, INC.2020-03-28

© 2023 FDA.report
This site is not affiliated with or endorsed by the FDA.