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510(k) K173511

ActiveCare TD-4121 Blood Glucose Monitoring System by Taidoc Technology Corporation — Product Code NBW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 12, 2018
Date Received
November 13, 2017
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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