Cleared Traditional

i-STAT G3+ cartridge with the i-STAT 1 System

K223857 · Abbott Point of Care, Inc. · Chemistry
Sep 2023
Decision
266d
Days
Class 2
Risk

About This 510(k) Submission

K223857 is an FDA 510(k) clearance for the i-STAT G3+ 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 September 15, 2023, 266 days after receiving the submission on December 23, 2022. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1120.

Submission Details

510(k) Number K223857 FDA.gov
FDA Decision Cleared SESE
Date Received December 23, 2022
Decision Date September 15, 2023
Days to Decision 266 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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