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510(k) K062182

DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520 by Dade Behring, Inc. — Product Code DLJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 2006
Date Received
July 31, 2006
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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  • K073072 — DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B (February 21, 2008)
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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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  • K082030 — DIMENSION VISTA CSAE CALIBRATOR, MODEL KC440 (August 22, 2008)
  • 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)
  • K033246 — PRECISET DAT THC AND PRECISET DAT THC 20 CALIBRATORS (December 2, 2003)