FDA 510(k), K151658, Gmate Origin Blood Glucose Monitoring System

FDA 510(k), K151658, Gmate Origin Blood Glucose Monitoring System

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510(K) Number: K151658
Device Name: Gmate Origin Blood Glucose Monitoring System
Manufacturer: LINDA CHAN
Device Classification Name: System, Test, Blood Glucose, Over The Counter
Regulation Number: NBW
Classification Product Code: 06/19/2015
Date Received: 12/01/2015
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Clinical Chemistry

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