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FDA 510(k)

GEM Premier ChemSTAT

K-Number: K183555 · 2019-02-16

ApplicantInstrumentation Laboratory CO
Decision Date2019-02-16
Product CodeJFY
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 K183555. The device is classified under product code JFY. 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 K183555.

When was GEM Premier ChemSTAT approved by the FDA?

GEM Premier ChemSTAT received FDA 510(k) clearance on 2019-02-16, under approval number K183555.

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 JFY.

Other Devices by Instrumentation Laboratory CO

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Related Devices (Code: JFY)

K152835URITEK TC-201 URINE CHEMISTRY TEST SYSTEMTeco Diagnostics, Inc. K161527Teco Creatinine Enzymatic Reagent KitTeco Diagnostics, Inc. K182038URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzerYd Diagnostics Corporation K182063VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated SystemOrtho-Clinical Diagnostics, Inc. K182384ACR LAB Urine Analysis Test SystemHealthy.Io, Ltd. K212223Atellica CH Enzymatic Creatinine_3 (ECre3)Siemens Healthcare Diagnostics, 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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