Name: Predicase
Price: 199 USD

K-number	K160415
Device name	GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation)
Applicant	Instrumentation Laboratory CO
Product code	GKF
Device class	Class II
Decision date	Dec 14, 2016
Decision	Substantially Equivalent
Regulation	864.5600

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Source

View the full FDA submission: accessdata.fda.gov

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GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation)

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