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FDA 510(k), K141656, GMATE MINI BLOOD GLUCOSE MONITORING SYSTEM, GMATE STEP BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k), K141656, GMATE MINI BLOOD GLUCOSE MONITORING SYSTEM, GMATE STEP BLOOD GLUCOSE MONITORING SYSTEM
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510(K) Number: K141656
Device Name: GMATE MINI BLOOD GLUCOSE MONITORING SYSTEM, GMATE STEP BLOOD GLUCOSE MONITORING SYSTEM
Manufacturer: LINDA CHAN
Device Classification Name: System, Test, Blood Glucose, Over The Counter
Regulation Number: NBW
Classification Product Code: 06/20/2014
Date Received: 10/02/2015
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Clinical Chemistry
Device Name: GMATE MINI BLOOD GLUCOSE MONITORING SYSTEM, GMATE STEP BLOOD GLUCOSE MONITORING SYSTEM
Manufacturer: LINDA CHAN
Device Classification Name: System, Test, Blood Glucose, Over The Counter
Regulation Number: NBW
Classification Product Code: 06/20/2014
Date Received: 10/02/2015
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Clinical Chemistry
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- Delivery: Approximately 1 to 2 weeks
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