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510(k) K073416

ARKRAY GLUCOCARD 01 BLOOD MONITORING SYSTEM by Arkray Factory USA, Inc. — Product Code CGA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 2008
Date Received
December 3, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Glucose Oxidase, Glucose
Device Class
Class II
Regulation Number
862.1345
Review Panel
CH
Submission Type

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