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510(k) K072036

ARCHITECT IVANCOMYCIN REAGENTS AND ARCHITECT IVANCOMYCIN CALIBRATORS, MODELS: 1P30-25 AND 1P30-01 by Biokit, S.A. — Product Code LEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 2008
Date Received
July 25, 2007
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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Other clearances for product code LEH

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  • K050419 — QMS VANCOMYCIN (April 1, 2005)
  • K043386 — VITROS CHEMISTRY PRODUCTS VANC REAGENT, CALIBRATOR KIT 11 AND TDM PERFORMANCE VE (February 7, 2005)
  • K032811 — CEDIA VANCOMYCIN ASSAY (November 24, 2003)
  • K020692 — EMIT 2000 VANCOMYCIN ASSAY (May 10, 2002)