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510(k) K102345

EASYMAX T1 SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL EPS10042 by Eps Bio Technology Corp. — Product Code NBW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 2011
Date Received
August 19, 2010
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Blood Glucose, Over The Counter
Device Class
Class II
Regulation Number
862.1345
Review Panel
CH
Submission Type

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  • K111728 — EMV3 SELF MONITORING BLOOD GLUCOSE SYSTEM, EMV3 PRO SELF MONITORING BLOOD GLUCOS (September 16, 2011)

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