Name: Predicase
Price: 199 USD

K-number	K160402
Device name	GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin)
Applicant	Instrumentation Laboratory CO
Product code	CGA
Device class	Class II
Decision date	Dec 14, 2016
Decision	Substantially Equivalent
Regulation	862.1345

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Source

View the full FDA submission: accessdata.fda.gov

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GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin)

Everything you need for a 510(k) submission. Nothing you don't.