Cleared Traditional

GEM Premier 7000 with IQM3

K223608 · Instrumentation Laboratory Company · Chemistry

Aug 2023

Decision

251d

Days

Class 2

Risk

About This 510(k) Submission

K223608 is an FDA 510(k) clearance for the GEM Premier 7000 with IQM3, a Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph (Class II — Special Controls, product code CHL), submitted by Instrumentation Laboratory Company (Bedford, US). The FDA issued a Cleared decision on August 10, 2023, 251 days after receiving the submission on December 2, 2022. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1120.

Submission Details

510(k) Number	K223608 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 02, 2022
Decision Date	August 10, 2023
Days to Decision	251 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF