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FDA 510(k), K964630, GLUCOMETER ELITE BLOOD GLUCOSE METER
FDA 510(k), K964630, GLUCOMETER ELITE BLOOD GLUCOSE METER
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510(K) Number: K964630
Device Name: GLUCOMETER ELITE BLOOD GLUCOSE METER
Manufacturer: BAYER CORP.
Device Classification Name: Glucose Oxidase, Glucose
Regulation Number: 862.1345
Classification Product Code: CGA
Date Received: 11/19/1996
Decision Date: 02/10/1997
Regulation Medical Specialty: Clinical Chemistry
Device Name: GLUCOMETER ELITE BLOOD GLUCOSE METER
Manufacturer: BAYER CORP.
Device Classification Name: Glucose Oxidase, Glucose
Regulation Number: 862.1345
Classification Product Code: CGA
Date Received: 11/19/1996
Decision Date: 02/10/1997
Regulation Medical Specialty: Clinical Chemistry
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