Cleared Special

AXSYM DIGOXIN III

K061249 · Abbott Laboratories · Toxicology
Jun 2006
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K061249 is an FDA 510(k) clearance for the AXSYM DIGOXIN III, a Enzyme Immunoassay, Digoxin (Class II — Special Controls, product code KXT), submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on June 2, 2006, 29 days after receiving the submission on May 4, 2006. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3320.

Submission Details

510(k) Number K061249 FDA.gov
FDA Decision Cleared SESE
Date Received May 04, 2006
Decision Date June 02, 2006
Days to Decision 29 days
Submission Type Special
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code KXT — Enzyme Immunoassay, Digoxin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3320

Similar Devices — KXT Enzyme Immunoassay, Digoxin

All 84
ADVIA Centaur? Digoxin assay
K193397 · Siemens Healthcare Diagnostics, Inc. · Jul 2021
Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II
K153301 · Roche Diagnostics · Apr 2016
RANDOX DIGOXIN ASSAY
K102346 · Randox Laboratories, Ltd. · Oct 2011
DIMENSION VISTA LOCI DIGOXIN FLEX REAGENT CARTRIDGE (DIGXN), MODEL K6435
K093441 · Siemens Healthcare Diagnostics · Apr 2010
ARCHITECT IDIGOXIN AND ARCHITECT IDIGOXIN CALIBRATORS, MODELS 1P32-25 AND IP32-01
K082953 · Biokit, S.A. · Dec 2008
BAYER ADVIA DIGOXIN ASSAY FOR THE INTEGRATED MODULE SYSTEM
K033007 · Bayer Diagnostics Corp. · Nov 2003