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510(k) K951059

CIBA CORNING ACS VANCOMYCIN IMMUNOASSAY by Ciba Corning Diagnostics Corp. — Product Code LEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 19, 1995
Date Received
March 7, 1995
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

Other clearances by Ciba Corning Diagnostics Corp.

  • K962559 — ACS CORTISOL IMMUNOASSAY (November 5, 1996)
  • K963251 — CIBA CORNING ACS;180 DPD ASSAY (October 15, 1996)
  • K961807 — CERTAIN HCT LEVEL A & LEVEL B/CVM HCT LEVELS 1,2,3, & 4 (July 26, 1996)
  • K961657 — CIBA CORNING 400 SYSTEM (June 25, 1996)
  • K962021 — CIBA CORNING 348 SYSTEM (June 24, 1996)
  • K962126 — ACS CKMB II IMMUNOASSAY (June 21, 1996)
  • K962041 — ACS LH2 IMMUNOASSAY (June 21, 1996)
  • K961510 — ACS FRT4 IMMUNOASSAY (June 17, 1996)
  • K960246 — LIQUID CARDIAC MARKER 1,2,3 ASSAYED (April 23, 1996)
  • K955873 — ACS PHENYTOIN ASSAY (March 11, 1996)

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)
  • 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)