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510(k) K142664

URight Hemoglobin A1c system, FORA A1c System by Taidoc Technology Corporation — Product Code LCP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 29, 2016
Date Received
September 18, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Assay, Glycosylated Hemoglobin
Device Class
Class II
Regulation Number
864.7470
Review Panel
HE
Submission Type

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