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FDA 510(k)

GEM Premier ChemSTAT

K-Number: K183546 · 2019-02-16

ApplicantInstrumentation Laboratory CO
Decision Date2019-02-16
Product CodeCGA
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 K183546. The device is classified under product code CGA. 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 K183546.

When was GEM Premier ChemSTAT approved by the FDA?

GEM Premier ChemSTAT received FDA 510(k) clearance on 2019-02-16, under approval number K183546.

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 CGA.

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Related Devices (Code: CGA)

K162282CardioChek Plus Test System, CardioChek Home Test SystemPolymer Technology Systems, Inc. D/B/A Pts Diagnostics K160402GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin)Instrumentation Laboratory CO K161818GEM Premier 3000Instrumentation Laboratory CO K153692Synermed Glucose Reagent, Synermed IR-1200 Chemistry AnalyzerInfrared Laboratory Systems, LLC (Dba Synermed) K163433VITROS Chemistry Products GLU SlidesOrtho Clinical Diagnostics K163271i-Stat Alinity System with i-Stat Glucose testAbbott 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.

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