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510(k) K151809

Alere Afinion HbA1c, Alere Afinion AS100 Analyzer by Alere Technologies AS — Product Code LCP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 2015
Date Received
July 2, 2015
Clearance Type
Special
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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