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510(k) K043386

VITROS CHEMISTRY PRODUCTS VANC REAGENT, CALIBRATOR KIT 11 AND TDM PERFORMANCE VERIFIERS I, II AND III by Ortho-Clinical Diagnostics, Inc. — Product Code LEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 2005
Date Received
December 9, 2004
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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