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510(k) K171650

Alere Afinion HbA1c and ACR on Afinion 2 analyzer by Abbott Rapid Diagnostics — Product Code LCP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 2017
Date Received
June 5, 2017
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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