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510(k) K202534

MTM301 Blood Glucose and Ketone Monitoring System by Apex BioTechnology Corp. — Product Code NBW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 6, 2022
Date Received
September 1, 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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