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510(k) K160202

Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL) by Siemens Healthcare Diagnostics, Inc. — Product Code LEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 2016
Date Received
January 28, 2016
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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  • K152245 — ONLINE TDM Vancomycin Gen.3 (January 8, 2016)
  • K123947 — ARCHITECT IVANCOMYCIN (August 29, 2013)
  • K072036 — ARCHITECT IVANCOMYCIN REAGENTS AND ARCHITECT IVANCOMYCIN CALIBRATORS, MODELS: 1P (March 19, 2008)
  • K063045 — IMMULITE 2000, IMMULITE 2500 VANCOMYCIN (December 5, 2006)
  • K060586 — ENZYME IMMUNOASSAY, VANCOMYCIN (May 11, 2006)
  • 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)