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510(k) K161299

BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring System by Apex BioTechnology Corp. — Product Code NBW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 2016
Date Received
May 9, 2016
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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