GEM Premier 5000
K-Number: K173403 · 2017-12-29
ApplicantInstrumentation Laboratory CO
Decision Date2017-12-29
Product CodeCHL
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
GEM Premier 5000 is a medical device manufactured by Instrumentation Laboratory CO. It received FDA 510(k) clearance on 2017-12-29 under approval number K173403. The device is classified under product code CHL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the GEM Premier 5000?
GEM Premier 5000 is a medical device that received FDA 510(k) clearance on 2017-12-29. It is manufactured by Instrumentation Laboratory CO. The 510(k) number is K173403.
When was GEM Premier 5000 approved by the FDA?
GEM Premier 5000 received FDA 510(k) clearance on 2017-12-29, under approval number K173403.
What company makes GEM Premier 5000?
GEM Premier 5000 is manufactured by Instrumentation Laboratory CO.
What is the FDA product code for GEM Premier 5000?
The FDA product code for GEM Premier 5000 is CHL.
Other Devices by Instrumentation Laboratory CO
K160225GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized Calcium), GEM CVP 5 tBili, GEM System Evaluator, GEM Hematocrit Evaluator
K160415GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation)
K160402GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin)
K160412GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2)
K160885HemosIL D-Dimer HS
K161818GEM Premier 3000
Related Devices (Code: CHL)
K160412GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2)Instrumentation Laboratory CO
K160153ABL90 FLEX PLUSRadiometer Medical Aps
K151978EDAN i15 Blood Gas and Chemistry Analysis System, EDAN i15 Calibrant Fluid Pack, EDAN i15 Blood Gas and Electrolyte Control, EDAN i15 Hematocrit ControlEdan Instruments, Inc.
K173797Stat Profile Prime Plus Analyzer SystemNova Biomedical Corporation
K200107epoc Blood Analysis SystemEpocal, Inc.
K200492i-STAT CG4+ Cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.