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510(k) K200256

ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay by Siemens Healthcare Diagnostics, Inc. — Product Code PDJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 2021
Date Received
February 3, 2020
Clearance Type
Special
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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