FDA.reportPublic FDA data

510(k) K983151

Device
Immage Immunochemistry System Digoxin (dig) Reagent
Applicant
BECKMAN COULTER, INC.
510(k) number
K983151
Product code
KXT
Decision
Substantially Equivalent (SESE)
Decision date
1998-11-05
Date received
1998-09-09
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
No

Applicant Contact#

Contact
RICHARD T ROSS
Address
200 S. Kraemer Blvd. W-110 Brea CA US 92822 92822

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
K033007BAYER ADVIA DIGOXIN ASSAY FOR THE INTEGRATED MODULE SYSTEMBayer Diagnostics Corp.2003-11-14
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
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