Cleared Traditional

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

K223710 · Abbott Point of Care, Inc. · Chemistry
Jul 2023
Decision
228d
Days
Class 2
Risk

About This 510(k) Submission

K223710 is an FDA 510(k) clearance for the i-STAT CG8+ cartridge with the i-STAT 1 System, a Glucose Oxidase, Glucose (Class II — Special Controls, product code CGA), submitted by Abbott Point of Care, Inc. (Princton, US). The FDA issued a Cleared decision on July 28, 2023, 228 days after receiving the submission on December 12, 2022. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K223710 FDA.gov
FDA Decision Cleared SESE
Date Received December 12, 2022
Decision Date July 28, 2023
Days to Decision 228 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CGA — Glucose Oxidase, Glucose
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1345

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