Cleared Traditional

i-STAT CG4+ cartridge with the i-STAT 1 System

K244014 · Abbott Point of Care, Inc. · Chemistry
May 2025
Decision
127d
Days
Class 2
Risk

About This 510(k) Submission

K244014 is an FDA 510(k) clearance for the i-STAT CG4+ cartridge with the i-STAT 1 System, a Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph (Class II — Special Controls, product code CHL), submitted by Abbott Point of Care, Inc. (Princton, US). The FDA issued a Cleared decision on May 2, 2025, 127 days after receiving the submission on December 26, 2024. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1120.

Submission Details

510(k) Number K244014 FDA.gov
FDA Decision Cleared SESE
Date Received December 26, 2024
Decision Date May 02, 2025
Days to Decision 127 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CHL — Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1120

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