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510(k) K052017

CYCLOSPORINE EXTENDED RANGE ASSAY (CSAE) FLEX REAGENT CARTRIDGE, CATALOG # DF108 by Dade Behring, Inc. — Product Code MKW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 1, 2005
Date Received
July 26, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cyclosporine
Device Class
Class II
Regulation Number
862.1235
Review Panel
TX
Submission Type

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Other clearances for product code MKW

  • K080751 — ARCHITECT CYCLOSPORINE (September 11, 2008)
  • K071455 — ADVIA CENTAUR CYCLOSPORINE ASSAY AND CALIBRATOR (September 11, 2008)
  • K081992 — DIMENSION VISTA CSAE FLEX REGENT CARTRIDGE, MODEL K4108 (August 5, 2008)
  • K062236 — DIMENSION VISTA CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE (August 21, 2006)
  • K053061 — EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY (February 6, 2006)
  • K040761 — AXSYM CYCLOSPORINE (April 30, 2004)
  • K023208 — CEDIA CYCLOSPORINE PLUS ASSAY (October 24, 2002)
  • K023065 — CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE (October 16, 2002)