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510(k) K963158

Device
Abbott Axsym Digitoxin (modify)
Applicant
ABBOTT LABORATORIES
510(k) number
K963158
Product code
LFM
Decision
Substantially Equivalent (SESE)
Decision date
1996-09-10
Date received
1996-07-26
Regulation
862.3300
Classification name
Enzyme Immunoassay, Digitoxin
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
GRACE LEMIEUX
Address
Dept. 389, Ap30 200 Abbott Park Rd. Abbott Park IL US 60064 60064

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LFM#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K062024DIMENSION VISTA DIGITOXIN, DIGOXIN, GENTAMICIN, N-ACETYLPROCAINAMIDE, PHENYTOIN, THEOPHYLLINE FLEX REAGENT CARTRIDGEDade Behring, Inc.2006-07-28
K012112RANDOX DIGITOXINRandox Laboratories, Ltd.2002-01-11
K990251DGTX FLEX REAGENT CARTRIDGE, MODEL DF36Dade Behring, Inc.1999-03-31
K970546ACS DIGITOXINChiron Diagnostics Corp.1997-07-14
K954420AXSYM DIGITOXINAbbott Laboratories1995-12-29
K951631DIGOXIN ASSAY FOR THE TECCHNICON RA/OPERA SYSTEMS IN-VITRO DIAGNOSTIC SYSTEMSBayer Corp.1995-06-09
K943235IMMULITE DIGITOXINDiagnostic Products Corp.1994-10-27
K942610KODAK EXTACHEM CLINICAL CHEMISTRY SLIDE DIGOXIN (DGXN)Eastman Kodak Company1994-10-20
K942619EMIT 2000 DIGOXIN ASSAY/CALIBRATORSSyva Co.1994-09-20
K915465DIGITOXIN FPIA REAGENT SETSigma Diagnostics, Inc.1992-01-27
K913187INNOFLUOR(TM) DIGITOXIN REAGENT SETIntl. Bioclinical, Inc.1991-09-23
K913240DIGITOXIN (FPIA) KITTudor Laboratories, Inc.1991-09-06
K900013MILENIA (TM) DIGITOXINDiagnostic Products Corp.1990-03-09
K896021CEDIA DIGITOXIN ASSAYMicrogenics Corp.1989-11-08
K891094ACA(R) DIGITOXIN (DGTX) METHODE.I. Dupont DE Nemours & Co., Inc.1989-04-26