Cleared Traditional

BAYER ADVIA DIGOXIN ASSAY FOR THE INTEGRATED MODULE SYSTEM

K033007 · Bayer Diagnostics Corp. · Chemistry
Nov 2003
Decision
49d
Days
Class 2
Risk

About This 510(k) Submission

K033007 is an FDA 510(k) clearance for the BAYER ADVIA DIGOXIN ASSAY FOR THE INTEGRATED MODULE SYSTEM, a Enzyme Immunoassay, Digoxin (Class II — Special Controls, product code KXT), submitted by Bayer Diagnostics Corp. (Tarrytown, US). The FDA issued a Cleared decision on November 14, 2003, 49 days after receiving the submission on September 26, 2003. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3320.

Submission Details

510(k) Number K033007 FDA.gov
FDA Decision Cleared SESE
Date Received September 26, 2003
Decision Date November 14, 2003
Days to Decision 49 days
Submission Type Traditional
Review Panel Chemistry (CH)
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
AXSYM DIGOXIN III
K061249 · Abbott Laboratories · Jun 2006