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510(k) K173206

SEKURE HbA1c Assay by Sekisui Diagnostics P.E.I., Inc. — Product Code PDJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 12, 2018
Date Received
October 2, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hemoglobin A1c Test System
Device Class
Class II
Regulation Number
862.1373
Review Panel
CH
Submission Type

Quantitative determination of Hemoglobin A1c to aid in the diagnosis of diabetes.

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