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510(k) K121842

ARCHITECT HBA1C, ARCHITECT HBA1C, AND ARCHITECT HBA1C by Axis-Shield Diagnostics, Ltd. — Product Code LCP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 2012
Date Received
June 25, 2012
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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