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510(k) K093441

DIMENSION VISTA LOCI DIGOXIN FLEX REAGENT CARTRIDGE (DIGXN), MODEL K6435 by Siemens Healthcare Diagnostics — Product Code KXT

K093441 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Diagnostics for the device "DIMENSION VISTA LOCI DIGOXIN FLEX REAGENT CARTRIDGE (DIGXN), MODEL K6435". The FDA issued a decision of Substantially Equivalent on April 7, 2010. The device falls under product code KXT (Enzyme Immunoassay, Digoxin), a Class II device regulated under 21 CFR 862.3320. Siemens Healthcare Diagnostics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 7, 2010
Date Received
November 5, 2009
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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Other clearances for product code KXT

  • K193397 — ADVIA Centaur® Digoxin assay (July 16, 2021)
  • K153301 — Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II (April 8, 2016)
  • K102346 — RANDOX DIGOXIN ASSAY (October 14, 2011)
  • 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)
  • K011302 — RANDOX DIGOXIN (July 2, 2001)
  • K011920 — EMIT 2000 DIGOXIN ASSAY, MODEL OSR4H229 (July 2, 2001)

FDA data resources