NBW — System, Test, Blood Glucose, Over The Counter Class II

FDA Device Classification

Classification Details

Product Code
NBW
Device Class
Class II
Regulation Number
862.1345
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K250085acon laboratoriesOn Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GKOctober 10, 2025
K243060guangdong transtek medical electronics coTeleRPM Gen2 Blood Glucose Monitoring SystemJanuary 30, 2025
K240637bionime corporationRIGHTEST Blood Glucose Monitoring System Max TelNovember 4, 2024
K240640sejoy biomedical coSejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose MonitoriOctober 8, 2024
K241787ascensia diabetes care u.sCONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood GlucAugust 27, 2024
K222126vivachek biotech (hangzhou) coVivaChek™ Fad Blood Glucose Monitoring System, VivaChek™ Fad Smart Blood GlucoseAugust 16, 2024
K241304agamatrixWaveSense Jazz Blood Glucose Monitoring SystemJune 6, 2024
K231679ascensia diabetes careCONTOUR® PLUS BLUE Blood Glucose Monitoring SystemFebruary 23, 2024
K231192bionime corporationRIGHTEST Blood Glucose Monitoring System Max TelJanuary 19, 2024
K233058vivachek biotech (hangzhou) coVivaChek Link Plus Blood Glucose Monitoring SystemDecember 22, 2023
K231476sinocareTRUENESS™ AIR Blood Glucose Monitoring System; TRUENESS™ Blood Glucose MonitorinDecember 1, 2023
K230625i-sensReliOn Premier BLU Blood Glucose Monitoring SystemAugust 10, 2023
K213131roche diabetes careAccu-Chek Guide Solo diabetes manager blood glucose monitoring systemAugust 10, 2023
K223722mio labsMIO Blood Glucose Monitoring SystemJune 28, 2023
K222234apex biotechnologyGlucoSure ADVANCE Link Blood Glucose Monitoring SystemDecember 21, 2022
K223293ascensia diabetes care u.sCONTOUR® NEXT GEN Blood Glucose Monitoring SystemNovember 18, 2022
K220421apex biotechnologyBGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring SysNovember 4, 2022
K213061ok biotech coSuperCheck Pro Blood Glucose Monitoring SystemOctober 7, 2022
K212248hmd biomedicalGlucoLeader Enhance 2 Blood Glucose Monitoring SystemAugust 29, 2022
K212140apex biotechnologyGlucoSure Link Blood Glucose Monitoring SystemAugust 25, 2022