Home / 510(k) Clearances / K101457

510(k) K101457

EASYPLUS MINI R9N SELF MONITORING BLOOD GLUCOSE SYSTEM MODEL EPS10031 by Eps Bio Technology Corp. — Product Code NBW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 2010
Date Received
May 26, 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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