Home / 510(k) Clearances / K210958

510(k) K210958

i-STAT CHEM8+ cartridge with the i-STAT 1 System by Abbott Point of Care, Inc. — Product Code CGA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 2021
Date Received
March 31, 2021
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 Abbott Point of Care, Inc.

  • K244014 — i-STAT CG4+ cartridge with the i-STAT 1 System (May 2, 2025)
  • K240984 — i-STAT hs-TnI cartridge with the i-STAT 1 System (January 3, 2025)
  • K234143 — i-STAT TBI Cartridge with the i-STAT Alinity System (March 27, 2024)
  • K230285 — i-STAT CG8+ cartridge with the i-STAT 1 System (October 27, 2023)
  • K230300 — i-STAT CG8+ cartridge with the i-STAT 1 System (October 27, 2023)
  • K230275 — i-STAT CG8+ cartridge with the i-STAT 1 System (October 27, 2023)
  • K223857 — i-STAT G3+ cartridge with the i-STAT 1 System (September 15, 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)
  • K200492 — i-STAT CG4+ Cartridge with the i-STAT 1 System (April 9, 2020)

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)
  • K200349 — Stat Profile Prime Plus Analyzer System (March 13, 2020)
  • K183678 — i-STAT CHEM8+ cartridge with the i-STAT 1 System (February 7, 2020)
  • K190520 — VITROS XT Chemistry Products GLU-Ca Slides (April 3, 2019)