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510(k) K110056

AFINION ANALYZER by Axis-Shield Poc AS — Product Code LCP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 15, 2011
Date Received
January 10, 2011
Clearance Type
Traditional
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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