Home / 510(k) Clearances / K202885

510(k) K202885

GlucoSure HT Plus Blood Glucose Monitoring System by Apex BioTechnology Corp. — Product Code NBW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 2021
Date Received
September 28, 2020
Clearance Type
Special
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 Apex BioTechnology Corp.

  • K242209 — UASure II Blood Uric Acid Monitoring System (April 4, 2025)
  • K222234 — GlucoSure ADVANCE Link Blood Glucose Monitoring System (December 21, 2022)
  • K220421 — BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring Sys (November 4, 2022)
  • K212140 — GlucoSure Link Blood Glucose Monitoring System (August 25, 2022)
  • K202534 — MTM301 Blood Glucose and Ketone Monitoring System (April 6, 2022)
  • K213887 — GAL-1A Plus Blood Glucose Monitoring System (March 29, 2022)
  • K201880 — MultiSure GK Link Blood Glucose and Ketone Monitoring System (October 15, 2021)
  • K182593 — KET-1 Blood Ketone Monitoring System (December 18, 2018)
  • K182992 — BGM014 Blood Glucose Monitoring System (November 28, 2018)
  • K170267 — BGM009 Plus Blood Glucose Monitoring System (March 9, 2017)

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)
  • K231192 — RIGHTEST Blood Glucose Monitoring System Max Tel (January 19, 2024)
  • K233058 — VivaChek Link Plus Blood Glucose Monitoring System (December 22, 2023)