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510(k) K053411

DRI HEMOGLOBIN A1C ASSAY AND CALIBRATORS by Microgenics Corp. — Product Code LCP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 2006
Date Received
December 7, 2005
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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  • K101754 — THERMO SCIENTIFIC CEDIA OPIATE OFT ASSAY (April 8, 2011)

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