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510(k) K101037

EG V1 (BL) SELF MONITORING GLUCOSE TEST SYSTEM MODEL: EPS10017 by Eps Bio Technology Corp. — Product Code LFR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 2011
Date Received
April 14, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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