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510(k) K081895

ADVIA CHEMISTRY HEMOGLOBIN A1C, ADVIA CHEMISTRY A1C CALIBRATORS by Siemens Medical Solutions Diagnostics — Product Code LCP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 8, 2009
Date Received
July 3, 2008
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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