Name: Predicase
Price: 199 USD

K-number	K160225
Device name	GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized Calcium), GEM CVP 5 tBili, GEM System Evaluator, GEM Hematocrit Evaluator
Applicant	Instrumentation Laboratory CO
Product code	JGS
Device class	Class II
Decision date	Dec 14, 2016
Decision	Substantially Equivalent
Regulation	862.1665

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Source

View the full FDA submission: accessdata.fda.gov

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

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