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510(k) K033007

Device
BAYER ADVIA DIGOXIN ASSAY FOR THE INTEGRATED MODULE SYSTEM
Applicant
Bayer Diagnostics Corp.
510(k) number
K033007
Product code
KXT
Decision
Substantially Equivalent (SESE)
Decision date
2003-11-14
Date received
2003-09-26
Regulation
862.3320
Classification name
Enzyme Immunoassay, Digoxin
Medical specialty
Clinical Toxicology
Review panel
Clinical Toxicology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
KENNETH T EDDS
Address
511 Benedict Ave. Tarrytown NY US 10591 10591

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KXT#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K193397ADVIA Centaur® Digoxin assaySiemens Healthcare Diagnostics, Inc.2021-07-16
K153301Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac IIRoche Diagnostics2016-04-08
K102346RANDOX DIGOXIN ASSAYRandox Laboratories, Ltd.2011-10-14
K093441DIMENSION VISTA LOCI DIGOXIN FLEX REAGENT CARTRIDGE (DIGXN), MODEL K6435Siemens Healthcare Diagnostics2010-04-07
K082953ARCHITECT IDIGOXIN AND ARCHITECT IDIGOXIN CALIBRATORS, MODELS 1P32-25 AND IP32-01Biokit, S.A.2008-12-22
K061249AXSYM DIGOXIN IIIAbbott Laboratories2006-06-02
K023058QMS DIGOXIN REAGENT SYSTEM ON THE ABBOTT AEROSET SYSTEMSeradyn2002-10-24
K012301IMMULITE 2000 DIGOXIN, MODELS L2KDI2 (200 TESTS) AND L2KDI6 (600 TESTS)Diagnostic Products Corp.2001-09-19
K011920EMIT 2000 DIGOXIN ASSAY, MODEL OSR4H229Syva Co., Dade Behring, Inc.2001-07-02
K011302RANDOX DIGOXINRandox Laboratories, Ltd.2001-07-02
K983323DIGOXIN IMMUNOASSAYDiagnostic Reagents, Inc.1998-11-12
K983151IMMAGE IMMUNOCHEMISTRY SYSTEM DIGOXIN (DIG) REAGENTBeckman Coulter, Inc.1998-11-05
K982935SYNCHRON SYSTEMS DIGOXIN (DIGN) REAGENT, SYNCHRON SYSTEMS DRUG CALIBRATORBeckman Coulter, Inc.1998-10-14
K980521DIGOXIN ASSAY FOR THE TECHNICON RA / OPERA SYSTEMSBayer Corp.1998-04-02
K973112ELECSYS DIGOXINBoehringer Mannheim Corp.1997-10-10