Cleared Special

GEM Premier 5000

K203790 · Instrumentation Laboratory CO · Chemistry
Aug 2021
Decision
235d
Days
Class 2
Risk

About This 510(k) Submission

K203790 is an FDA 510(k) clearance for the GEM Premier 5000, a Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph (Class II — Special Controls, product code CHL), submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on August 20, 2021, 235 days after receiving the submission on December 28, 2020. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1120.

Submission Details

510(k) Number K203790 FDA.gov
FDA Decision Cleared SESE
Date Received December 28, 2020
Decision Date August 20, 2021
Days to Decision 235 days
Submission Type Special
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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