Cleared Traditional

GEM Premier 5000

K173403 · Instrumentation Laboratory CO · Chemistry
Dec 2017
Decision
59d
Days
Class 2
Risk

About This 510(k) Submission

K173403 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 December 29, 2017, 59 days after receiving the submission on October 31, 2017. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1120.

Submission Details

510(k) Number K173403 FDA.gov
FDA Decision Cleared SESE
Date Received October 31, 2017
Decision Date December 29, 2017
Days to Decision 59 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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