Home / 510(k) Clearances / K231192

510(k) K231192

RIGHTEST Blood Glucose Monitoring System Max Tel by Bionime Corporation — Product Code NBW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 19, 2024
Date Received
April 27, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Blood Glucose, Over The Counter
Device Class
Class II
Regulation Number
862.1345
Review Panel
CH
Submission Type

Other clearances by Bionime Corporation

  • K240637 — RIGHTEST Blood Glucose Monitoring System Max Tel (November 4, 2024)
  • K221062 — RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device (September 26, 2022)
  • K190564 — Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitori (June 2, 2019)
  • K173638 — Rightest Blood Glucose Monitoring System Max, Rightest Blood Glucose Monitoring (August 17, 2018)
  • K173139 — Rightest Blood Glucose Monitoring System Wiz, Rightest Blood Glucose Monitoring (June 19, 2018)
  • K170143 — GE Blood Glucose Monitoring System 180, GE Blood Glucose Monitoring System 182, (July 6, 2017)
  • K161790 — iGlucose Blood Glucose Monitoring System (May 2, 2017)
  • K140210 — RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM ( GM720, RIGHTEST PROFESSIONAL BGMS GM7 (August 22, 2014)
  • K133003 — RIGHTEST CONTROL SOLUTION (October 24, 2013)
  • K123008 — RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM GM700 GE GE200 BLOOD GLUCOSE MONITORING (January 25, 2013)

Other clearances for product code NBW

  • K250085 — On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK (October 10, 2025)
  • K243060 — TeleRPM Gen2 Blood Glucose Monitoring System (January 30, 2025)
  • K240637 — RIGHTEST Blood Glucose Monitoring System Max Tel (November 4, 2024)
  • K240640 — Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitori (October 8, 2024)
  • K241787 — CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Gluc (August 27, 2024)
  • K222126 — VivaChek™ Fad Blood Glucose Monitoring System, VivaChek™ Fad Smart Blood Glucose (August 16, 2024)
  • K241304 — WaveSense Jazz Blood Glucose Monitoring System (June 6, 2024)
  • K231679 — CONTOUR® PLUS BLUE Blood Glucose Monitoring System (February 23, 2024)
  • K233058 — VivaChek Link Plus Blood Glucose Monitoring System (December 22, 2023)
  • K231476 — TRUENESS™ AIR Blood Glucose Monitoring System; TRUENESS™ Blood Glucose Monitorin (December 1, 2023)