Home / 510(k) Clearances / K113547

510(k) K113547

GAL-1E BLOOD GLUCOSE MONITORING SYSTEM GAL-1E BLOOD GLUCOSE TEST STRIPS GAL-1E MULTI BLOOD GLUCOSE MONITORING SYSTEM GAL by Apex BioTechnology Corp. — Product Code CGA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 2012
Date Received
December 1, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Glucose Oxidase, Glucose
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)
  • K202885 — GlucoSure HT Plus Blood Glucose Monitoring System (September 15, 2021)
  • K182593 — KET-1 Blood Ketone Monitoring System (December 18, 2018)
  • K182992 — BGM014 Blood Glucose Monitoring System (November 28, 2018)

Other clearances for product code CGA

  • K210933 — YSI 2900C Biochemistry Analyzer (September 30, 2024)
  • K220328 — EasyStat 300 (July 26, 2024)
  • K223179 — Cholestech LDX ™ System (September 20, 2023)
  • K223755 — i-STAT G cartridge with the i-STAT 1 System (September 11, 2023)
  • K223710 — i-STAT CG8+ cartridge with the i-STAT 1 System (July 28, 2023)
  • K223090 — GEM Premier ChemSTAT (January 27, 2023)
  • K203549 — Nova Primary Glucose Analyzer System (October 18, 2022)
  • K210958 — i-STAT CHEM8+ cartridge with the i-STAT 1 System (August 13, 2021)
  • K200349 — Stat Profile Prime Plus Analyzer System (March 13, 2020)
  • K183678 — i-STAT CHEM8+ cartridge with the i-STAT 1 System (February 7, 2020)