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510(k) K181273

GLUCOCARD Shine Connex Blood Glucose Monitoring System, GLUCOCARD Shine Express Blood Glucose Monitoring System by I-Sens, Inc. — Product Code NBW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 1, 2018
Date Received
May 14, 2018
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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