Cleared Traditional

GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized Calcium), GEM CVP 5 tBili, GEM System Evaluator, GEM Hematocrit Evaluator

K160225 · Instrumentation Laboratory CO · Chemistry

Dec 2016

Decision

320d

Days

Class 2

Risk

About This 510(k) Submission

K160225 is an FDA 510(k) clearance for the GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized Calcium), GEM CVP 5 tBili, GEM System Evaluator, GEM Hematocrit Evaluator, a Electrode, Ion Specific, Sodium (Class II — Special Controls, product code JGS), submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on December 14, 2016, 320 days after receiving the submission on January 29, 2016. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1665.

Submission Details

510(k) Number	K160225 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 29, 2016
Decision Date	December 14, 2016
Days to Decision	320 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF