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510(k) K983151

IMMAGE IMMUNOCHEMISTRY SYSTEM DIGOXIN (DIG) REAGENT by Beckman Coulter, Inc. — Product Code KXT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 1998
Date Received
September 9, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Digoxin
Device Class
Class II
Regulation Number
862.3320
Review Panel
TX
Submission Type

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  • K082953 — ARCHITECT IDIGOXIN AND ARCHITECT IDIGOXIN CALIBRATORS, MODELS 1P32-25 AND IP32-0 (December 22, 2008)
  • K061249 — AXSYM DIGOXIN III (June 2, 2006)
  • K033007 — BAYER ADVIA DIGOXIN ASSAY FOR THE INTEGRATED MODULE SYSTEM (November 14, 2003)
  • K023058 — QMS DIGOXIN REAGENT SYSTEM ON THE ABBOTT AEROSET SYSTEM (October 24, 2002)
  • K012301 — IMMULITE 2000 DIGOXIN, MODELS L2KDI2 (200 TESTS) AND L2KDI6 (600 TESTS) (September 19, 2001)
  • K011920 — EMIT 2000 DIGOXIN ASSAY, MODEL OSR4H229 (July 2, 2001)