Home / 510(k) Clearances / K081796

510(k) K081796

EASYPLUS MINI R2N SELF MONITORING GLUCOSE TEST SYSTEM by Eps Bio Technology Corp. — Product Code NBW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 23, 2009
Date Received
June 25, 2008
Clearance Type
Traditional
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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