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FDA 510(k), K150299, Gmate SMART Blood Glucose Monitoring System
FDA 510(k), K150299, Gmate SMART Blood Glucose Monitoring System
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$149.00 USD
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510(K) Number: K150299
Device Name: Gmate SMART Blood Glucose Monitoring System
Manufacturer: Linda Chan
Device Classification Name: System, Test, Blood Glucose, Over The Counter
Regulation Number: NBW
Classification Product Code: 02/06/2015
Date Received: 11/19/2015
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Clinical Chemistry
Device Name: Gmate SMART Blood Glucose Monitoring System
Manufacturer: Linda Chan
Device Classification Name: System, Test, Blood Glucose, Over The Counter
Regulation Number: NBW
Classification Product Code: 02/06/2015
Date Received: 11/19/2015
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
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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