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510(k) K082417

GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, MODEL 73110 by Arkray Factory USA, Inc. — Product Code CGA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 2008
Date Received
August 22, 2008
Clearance Type
Special
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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