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510(k) K152245

ONLINE TDM Vancomycin Gen.3 by Roche Diagnostics Operations (Rdo) — Product Code LEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 8, 2016
Date Received
August 10, 2015
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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  • K160571 — cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay (December 19, 2016)
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  • K160570 — Creatine Kinase (May 25, 2016)
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Other clearances for product code LEH

  • K222439 — Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc) (August 8, 2023)
  • K160202 — Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL) (April 27, 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)