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510(k) K011112

CYCLOSPORINE CALIBRATOR by Dade Behring, Inc. — Product Code DLJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 17, 2001
Date Received
April 11, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrators, Drug Specific
Device Class
Class II
Regulation Number
862.3200
Review Panel
TX
Submission Type

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  • K072965 — DIMENSION VISTA C1 IN; FLEX REAGENT CARTRIDGE, CAL, CON (December 21, 2007)

Other clearances for product code DLJ

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  • K091617 — QMS LIDOCAINE CALIBRATORS, MODEL 0374678 (July 17, 2009)
  • K082030 — DIMENSION VISTA CSAE CALIBRATOR, MODEL KC440 (August 22, 2008)
  • K062182 — DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520 (September 14, 2006)
  • K062199 — DIMENSION VISTA SYSTEM DRUG 3 CALIBRATOR (DRUG 3 CAL - KC430) (September 6, 2006)
  • K061503 — DIMENSION CYCLOSPORINE EXTENDED RANGE CALIBRATOR (DC108A) (June 22, 2006)
  • K060503 — DIMENSION TACR CALIBRATOR, MODEL DC107 (May 18, 2006)
  • K053108 — DIMENSION CSAE CYCLOSPORINE EXTENDED RANGE CALIBRATOR, MODEL DC108 (February 16, 2006)
  • K052015 — DIMENSION EXTENDED RANGE CYCLOSPORINE CALIBRATOR, CATALOG # DC108 (September 12, 2005)
  • K033601 — LABONE MICRO-PLATE COTININE EIA (February 10, 2004)