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510(k) K032811

CEDIA VANCOMYCIN ASSAY by Microgenics Corp. — Product Code LEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 2003
Date Received
September 9, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Vancomycin
Device Class
Class II
Regulation Number
862.3950
Review Panel
TX
Submission Type

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  • K101754 — THERMO SCIENTIFIC CEDIA OPIATE OFT ASSAY (April 8, 2011)

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