Cleared Special

GEM Premier ChemSTAT

K223090 · Instrumentation Laboratory CO · Chemistry
Jan 2023
Decision
119d
Days
Class 2
Risk

About This 510(k) Submission

K223090 is an FDA 510(k) clearance for the GEM Premier ChemSTAT, a Glucose Oxidase, Glucose (Class II — Special Controls, product code CGA), submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on January 27, 2023, 119 days after receiving the submission on September 30, 2022. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K223090 FDA.gov
FDA Decision Cleared SESE
Date Received September 30, 2022
Decision Date January 27, 2023
Days to Decision 119 days
Submission Type Special
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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