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510(k) K953016

Device
Axsym Theophylline Ii
Applicant
ABBOTT LABORATORIES
510(k) number
K953016
Product code
LGS
Decision
Substantially Equivalent (SESE)
Decision date
1995-08-24
Date received
1995-06-29
Regulation
862.3880
Classification name
Fluorescence Polarization Immunoassay, Theophylline
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: 09v8 Bldg: Ap5-2 100 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 LGS#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K070810ARCHITECT I THEOPHYLLINE REAGENTS AND CALIBRATORS (A-F)Biokit, S.A.2007-06-08
K955567INNOFLUOR THEOPHYLLINE ASSAY SYSTEMOxis Intl., Inc.1996-01-24
K951169CIBA CORINING ACS THEOPHYLLINE IMMUNOASSAYCiba Corning Diagnostics Corp.1995-06-20
K942991QMS THEOPHYLLINE CSSeradyn, Inc.1994-09-09
K932127TDX/TDXFLX & TDXFLX THEOPHYLLINE MONOCLONAL IIAbbott Laboratories1993-08-09
K922991ABBOTT TDX/TDXFLX AND TDXFLX THEOPHYLLINEAbbott Laboratories1992-08-27
K900706MODIFIED ACCUFLUOR THEOPHYLLINE REAGENT & CALIBRAInnotron of Oregon, Inc.1990-04-12
K894529FPR THEOPHYLLINE KITColony Laboratories, Inc.1989-09-15
K871484COBAS FP REAGENTS FOR THEOPHYLLINE & CALIBRATORSRoche Diagnostic Systems, Inc.1987-05-28
K870277MONITORX LASERX THEOPHYLLINE REAGENT SETAmerican Monitor Corp.1987-02-18
K850629INNOFLUOR THEOPHYLLINEInnotron Diagnostics1985-03-12
K843826COBAS IMMUNOASSAY FOR THEOPHYLLINE & CALRoche Diagnostic Systems, Inc.1985-02-01