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510(k) K214117

Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 Analyzer by Abbott Diagnostics Technologies AS — Product Code LCP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 2023
Date Received
December 30, 2021
Clearance Type
Dual Track
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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