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510(k) K023065

CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE by Dade Behring, Inc. — Product Code MKW

K023065 is an FDA 510(k) premarket notification submitted by Dade Behring, Inc. for the device "CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE". The FDA issued a decision of Substantially Equivalent on October 16, 2002. The device falls under product code MKW (Cyclosporine), a Class II device regulated under 21 CFR 862.1235. Dade Behring, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 2002
Date Received
September 16, 2002
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

Other clearances by Dade Behring, Inc.

  • K093848 — PT-MULTI-CALIBRATOR, MODEL OPAT07 (December 20, 2010)
  • K081161 — DIMENSION VISTA SYSTEM IGG FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEI (July 28, 2008)
  • K081249 — DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROT (July 21, 2008)
  • K071603 — DIMENSION VISTA CARCINOEMBRYONIC ANTIGEN FLEX REAGENT CARTRIDGE (CEA) (June 25, 2008)
  • K071597 — DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (June 4, 2008)
  • K073604 — DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CAR (March 13, 2008)
  • K073561 — DIMENSION VISTA SYSTEM IMMUNOGLOBULIN G FLEX REAGENT CARTRIDGE, DIMENSION VISTA (February 26, 2008)
  • K073072 — DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B (February 21, 2008)
  • K073055 — DIMENSION ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE WITH MODEL DF270 (January 3, 2008)
  • K072965 — DIMENSION VISTA C1 IN; FLEX REAGENT CARTRIDGE, CAL, CON (December 21, 2007)

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)
  • K052017 — CYCLOSPORINE EXTENDED RANGE ASSAY (CSAE) FLEX REAGENT CARTRIDGE, CATALOG # DF108 (September 1, 2005)
  • K040761 — AXSYM CYCLOSPORINE (April 30, 2004)
  • K023208 — CEDIA CYCLOSPORINE PLUS ASSAY (October 24, 2002)

FDA data resources