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510(k) K244014

i-STAT CG4+ cartridge with the i-STAT 1 System by Abbott Point of Care, Inc. — Product Code CHL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 2025
Date Received
December 26, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Device Class
Class II
Regulation Number
862.1120
Review Panel
CH
Submission Type

Other clearances by Abbott Point of Care, Inc.

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  • K230275 — 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)
  • K230285 — 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)
  • K210958 — i-STAT CHEM8+ cartridge with the i-STAT 1 System (August 13, 2021)
  • K200492 — i-STAT CG4+ Cartridge with the i-STAT 1 System (April 9, 2020)

Other clearances for product code CHL

  • K240998 — ABL90 FLEX PLUS System (December 13, 2024)
  • K230285 — i-STAT CG8+ cartridge with the i-STAT 1 System (October 27, 2023)
  • K221900 — Stat Profile Prime Plus Analyzer System (September 29, 2023)
  • K223857 — i-STAT G3+ cartridge with the i-STAT 1 System (September 15, 2023)
  • K223608 — GEM Premier 7000 with IQM3 (August 10, 2023)
  • K211559 — EasyStat 300 (January 27, 2023)
  • K203790 — GEM Premier 5000 (August 20, 2021)
  • K200986 — OPTI® B-Lac Cassette (August 2, 2021)
  • K200107 — epoc Blood Analysis System (June 5, 2020)
  • K200492 — i-STAT CG4+ Cartridge with the i-STAT 1 System (April 9, 2020)