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FDA 510(k), K130886, GLOOKO DEVICE SYSTEM FOR GLOOKO LOGBOOK+ APPLICATION
FDA 510(k), K130886, GLOOKO DEVICE SYSTEM FOR GLOOKO LOGBOOK+ APPLICATION
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510(K) Number: K130886
Device Name: GLOOKO DEVICE SYSTEM FOR GLOOKO LOGBOOK+ APPLICATION
Manufacturer: GLOOKO, INC.
Device Classification Name: system, test, blood glucose, over the counter
Regulation Number: 862.1345
Classification Product Code: NBW
Date Received: 03/29/2013
Decision Date: 04/25/2013
Regulation Medical Specialty: Clinical Chemistry
Device Name: GLOOKO DEVICE SYSTEM FOR GLOOKO LOGBOOK+ APPLICATION
Manufacturer: GLOOKO, INC.
Device Classification Name: system, test, blood glucose, over the counter
Regulation Number: 862.1345
Classification Product Code: NBW
Date Received: 03/29/2013
Decision Date: 04/25/2013
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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