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510(k) K963835

DIGOXIN ENZYME IMMUNOASSAY by Diagnostic Reagents, Inc. — Product Code KXT

K963835 is an FDA 510(k) premarket notification submitted by Diagnostic Reagents, Inc. for the device "DIGOXIN ENZYME IMMUNOASSAY". The FDA issued a decision of Substantially Equivalent on December 10, 1996. The device falls under product code KXT (Enzyme Immunoassay, Digoxin), a Class II device regulated under 21 CFR 862.3320. Diagnostic Reagents, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 1996
Date Received
September 24, 1996
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

Other clearances by Diagnostic Reagents, Inc.

  • K983268 — MODIFICATION OF TRICYCLIC SERUM TOX EIA ASSAY (November 18, 1998)
  • K983812 — NAPA EIA ASSAY (November 16, 1998)
  • K983323 — DIGOXIN IMMUNOASSAY (November 12, 1998)
  • K983280 — VANCOMYCIN EIA ASSAY (November 6, 1998)
  • K983159 — DRUGS OF ABUSE URINE CALIBRATORS AND CONTROLS (November 5, 1998)
  • K973102 — LIDOCAINE EIA ASSAY (September 12, 1997)
  • K972835 — 50NG/ML COCAINE METABOLITE CALIBRATOR (August 28, 1997)
  • K972526 — METHADONE EIA ASSAY (August 4, 1997)
  • K964212 — QUINIDINE ENZYME IMMUNOASSAY (December 18, 1996)
  • K962463 — PROCAINAMIDE ENZYME IMMUNOASSAY (August 14, 1996)

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)
  • K093441 — DIMENSION VISTA LOCI DIGOXIN FLEX REAGENT CARTRIDGE (DIGXN), MODEL K6435 (April 7, 2010)
  • 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)

FDA data resources