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510(k) K161687

D-10 Hemoglobin A1c Program by Bio-Rad Laboratories, Inc. — Product Code PDJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 14, 2016
Date Received
June 17, 2016
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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