FDA 510(k) Applications for Medical Device Product Code "LGS"
(Fluorescence Polarization Immunoassay, Theophylline)

FDA 510(k) Number Applicant Device Name Decision Date
K922991 ABBOTT LABORATORIES ABBOTT TDX/TDXFLX AND TDXFLX THEOPHYLLINE 08/27/1992
K953016 ABBOTT LABORATORIES AXSYM THEOPHYLLINE II 08/24/1995
K932127 ABBOTT LABORATORIES TDX/TDXFLX & TDXFLX THEOPHYLLINE MONOCLONAL II 08/09/1993
K870277 AMERICAN MONITOR CORP. "MONITORX LASERX THEOPHYLLINE REAGENT SET" 02/18/1987
K070810 BIOKIT S.A. ARCHITECT I THEOPHYLLINE REAGENTS AND CALIBRATORS (A-F) 06/08/2007
K951169 CIBA CORNING DIAGNOSTICS CORP. CIBA CORINING ACS THEOPHYLLINE IMMUNOASSAY 06/20/1995
K894529 COLONY LABORATORIES, INC. FPR THEOPHYLLINE KIT 09/15/1989
K850629 INNOTRON DIAGNOSTICS INNOFLUOR THEOPHYLLINE 03/12/1985
K900706 INNOTRON OF OREGON, INC. MODIFIED ACCUFLUOR THEOPHYLLINE REAGENT & CALIBRA 04/12/1990
K955567 OXIS INTL., INC. INNOFLUOR THEOPHYLLINE ASSAY SYSTEM 01/24/1996
K871484 ROCHE DIAGNOSTIC SYSTEMS, INC. COBAS FP REAGENTS FOR THEOPHYLLINE & CALIBRATORS 05/28/1987
K843826 ROCHE DIAGNOSTIC SYSTEMS, INC. COBAS IMMUNOASSAY FOR THEOPHYLLINE & CAL 02/01/1985
K942991 SERADYN, INC. QMS THEOPHYLLINE CS 09/09/1994


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