Home / 510(k) Clearances / K092104

510(k) K092104

ASSURE PLATINUM BLOOD GLUCOSE MONITORING SYSTEM by Arkray Factory USA, Inc. — Product Code CGA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 2009
Date Received
July 14, 2009
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 Arkray Factory USA, Inc.

  • K110709 — ARK CARE DIABETES MANAGMENT SYSTEM (May 19, 2011)
  • K093819 — ARKRAY DIABETES DATA MANAGEMENT SOFTWARE (SMBG VIEWER) (June 9, 2010)
  • K091102 — ASSURE PLATINUM AND GLUCOCARD VITAL BLOOD GLUCOSE MONITORING SYSTEMS (October 23, 2009)
  • K090653 — POCKETCHEM EZ BLOOD GLUCOSE MONITORING SYSTEM (October 9, 2009)
  • K090332 — ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 46001 (August 14, 2009)
  • K082417 — GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, MODEL 73110 (October 21, 2008)
  • K073416 — ARKRAY GLUCOCARD 01 BLOOD MONITORING SYSTEM (June 13, 2008)
  • K063771 — GLUCOCARD X-METER BLOOD GLUCOSE MONITORING SYSTEM (August 9, 2007)

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)