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FDA 510(k), K113636, BLOOD GLUCOSE MONITORING SYSTEM (GLUCOSE OXIDASE)
FDA 510(k), K113636, BLOOD GLUCOSE MONITORING SYSTEM (GLUCOSE OXIDASE)
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510(K) Number: K113636
Device Name: BLOOD GLUCOSE MONITORING SYSTEM (GLUCOSE OXIDASE)
Manufacturer: LINDA CHAN
Device Classification Name: Glucose Oxidase, Glucose
Regulation Number: CGA
Classification Product Code: KXA
Date Received: 12/09/2011
Decision Date: 03/08/2013
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Clinical Chemistry
Device Name: BLOOD GLUCOSE MONITORING SYSTEM (GLUCOSE OXIDASE)
Manufacturer: LINDA CHAN
Device Classification Name: Glucose Oxidase, Glucose
Regulation Number: CGA
Classification Product Code: KXA
Date Received: 12/09/2011
Decision Date: 03/08/2013
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Clinical Chemistry
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