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FDA 510(k), K121190, CONTOUR NEXT BLOOD GLUCOSE METER
FDA 510(k), K121190, CONTOUR NEXT BLOOD GLUCOSE METER
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510(K) Number: K121190
Device Name: CONTOUR NEXT BLOOD GLUCOSE METER
Manufacturer: BAYER HEALTHCARE LLC
Device Classification Name: glucose dehydrogenase, glucose
Regulation Number: 862.1345
Classification Product Code: LFR
Date Received: 04/19/2012
Decision Date: 07/26/2012
Regulation Medical Specialty: Clinical Chemistry
Device Name: CONTOUR NEXT BLOOD GLUCOSE METER
Manufacturer: BAYER HEALTHCARE LLC
Device Classification Name: glucose dehydrogenase, glucose
Regulation Number: 862.1345
Classification Product Code: LFR
Date Received: 04/19/2012
Decision Date: 07/26/2012
Regulation Medical Specialty: Clinical Chemistry
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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