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510(k) K013076

SYNCHRON SYSTEMS VANCOMYCIN REAGENT; SYNCHRON SYSTEMS VANCOMYCIN CALIBRATOR by Beckman Coulter, Inc. — Product Code LEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 2001
Date Received
September 14, 2001
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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