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FDA 510(k), K130265, CONTOUR NEXT EZ BLOOD GLUCOSE METER
FDA 510(k), K130265, CONTOUR NEXT EZ BLOOD GLUCOSE METER
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510(K) Number: K130265
Device Name: CONTOUR NEXT EZ BLOOD GLUCOSE METER
Manufacturer: BAYER HEALTHCARE LLC
Device Classification Name: system, test, blood glucose, over the counter
Regulation Number: 862.1345
Classification Product Code: NBW
Date Received: 02/04/2013
Decision Date: 06/23/2014
Regulation Medical Specialty: Clinical Chemistry
Device Name: CONTOUR NEXT EZ BLOOD GLUCOSE METER
Manufacturer: BAYER HEALTHCARE LLC
Device Classification Name: system, test, blood glucose, over the counter
Regulation Number: 862.1345
Classification Product Code: NBW
Date Received: 02/04/2013
Decision Date: 06/23/2014
Regulation Medical Specialty: Clinical Chemistry
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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