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FDA 510(k), K131230, GMATE SMART BLOOD GLUCOSE MONITORING SYSTEM, GMATE SMART APPLICATION
FDA 510(k), K131230, GMATE SMART BLOOD GLUCOSE MONITORING SYSTEM, GMATE SMART APPLICATION
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510(K) Number: K131230
Device Name: GMATE SMART BLOOD GLUCOSE MONITORING SYSTEM, GMATE SMART APPLICATION
Manufacturer: LINDA CHAN
Device Classification Name: System, Test, Blood Glucose, Over The Counter
Regulation Number: NBW
Classification Product Code: 04/30/2013
Date Received: 08/04/2014
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Clinical Chemistry
Device Name: GMATE SMART BLOOD GLUCOSE MONITORING SYSTEM, GMATE SMART APPLICATION
Manufacturer: LINDA CHAN
Device Classification Name: System, Test, Blood Glucose, Over The Counter
Regulation Number: NBW
Classification Product Code: 04/30/2013
Date Received: 08/04/2014
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Clinical Chemistry
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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