510(k) K160415

GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation) by Instrumentation Laboratory CO — Product Code GKF

K160415 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation)". The FDA issued a decision of Substantially Equivalent on December 14, 2016. The device falls under product code GKF (Instrument, Hematocrit, Automated), a Class II device regulated under 21 CFR 864.5600. Instrumentation Laboratory CO has at least 10 other 510(k) clearances on record.