Cleared Traditional

RANDOX DIGOXIN ASSAY

K102346 · Randox Laboratories, Ltd. · Chemistry
Oct 2011
Decision
421d
Days
Class 2
Risk

About This 510(k) Submission

K102346 is an FDA 510(k) clearance for the RANDOX DIGOXIN ASSAY, a Enzyme Immunoassay, Digoxin (Class II — Special Controls, product code KXT), submitted by Randox Laboratories, Ltd. (Crumlin, GB). The FDA issued a Cleared decision on October 14, 2011, 421 days after receiving the submission on August 19, 2010. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3320.

Submission Details

510(k) Number K102346 FDA.gov
FDA Decision Cleared SESE
Date Received August 19, 2010
Decision Date October 14, 2011
Days to Decision 421 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

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
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
AXSYM DIGOXIN III
K061249 · Abbott Laboratories · Jun 2006
BAYER ADVIA DIGOXIN ASSAY FOR THE INTEGRATED MODULE SYSTEM
K033007 · Bayer Diagnostics Corp. · Nov 2003