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510(k) K223857

i-STAT G3+ cartridge with the i-STAT 1 System by Abbott Point of Care, Inc. — Product Code CHL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 2023
Date Received
December 23, 2022
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

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  • K221900 — Stat Profile Prime Plus Analyzer System (September 29, 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)