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510(k) K201037

FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System by Taidoc Technology Corporation — Product Code NBW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 2022
Date Received
April 20, 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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