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510(k) K151321

D-100 HbA1c, D-100 HbA1c Calibrator Pack by Bio-Rad Laboratories, Inc. — Product Code PDJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 2015
Date Received
May 18, 2015
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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