Cleared Traditional

i-STAT CG8+ cartridge with the i-STAT 1 System

K230285 · Abbott Point of Care, Inc. · Chemistry
Oct 2023
Decision
267d
Days
Class 2
Risk

About This 510(k) Submission

K230285 is an FDA 510(k) clearance for the i-STAT CG8+ 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 October 27, 2023, 267 days after receiving the submission on February 2, 2023. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1120.

Submission Details

510(k) Number K230285 FDA.gov
FDA Decision Cleared SESE
Date Received February 02, 2023
Decision Date October 27, 2023
Days to Decision 267 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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