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510(k) K072686

AXSYM HBA1C REAGENTS, AXSYM HBA1C CALIBRATORS, AXSYM HBA1C CONTROLS by Axis-Shield Diagnostics, Ltd. — Product Code LCP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 2008
Date Received
September 24, 2007
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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