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FDA 510(k)

GEM Premier ChemSTAT

K-Number: K183549 · 2019-02-16

ApplicantInstrumentation Laboratory CO
Decision Date2019-02-16
Product CodeJGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GEM Premier ChemSTAT is a medical device manufactured by Instrumentation Laboratory CO. It received FDA 510(k) clearance on 2019-02-16 under approval number K183549. The device is classified under product code JGS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GEM Premier ChemSTAT?

GEM Premier ChemSTAT is a medical device that received FDA 510(k) clearance on 2019-02-16. It is manufactured by Instrumentation Laboratory CO. The 510(k) number is K183549.

When was GEM Premier ChemSTAT approved by the FDA?

GEM Premier ChemSTAT received FDA 510(k) clearance on 2019-02-16, under approval number K183549.

What company makes GEM Premier ChemSTAT?

GEM Premier ChemSTAT is manufactured by Instrumentation Laboratory CO.

What is the FDA product code for GEM Premier ChemSTAT?

The FDA product code for GEM Premier ChemSTAT is JGS.

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

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Related Devices (Code: JGS)

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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.

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