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510(k) K201880

MultiSure GK Link Blood Glucose and Ketone Monitoring System by Apex BioTechnology Corp. — Product Code NBW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 2021
Date Received
July 7, 2020
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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  • K182992 — BGM014 Blood Glucose Monitoring System (November 28, 2018)
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