LGS · Class II · 21 CFR 862.3880

FDA Product Code LGS: Fluorescence Polarization Immunoassay, Theophylline

Leading manufacturers include Abbott Laboratories, Roche Diagnostic Systems, Inc. and Biokit, S.A..

13
Total
13
Cleared
65d
Avg days
1985
Since

FDA 510(k) Cleared Fluorescence Polarization Immunoassay, Theophylline Devices (Product Code LGS)

13 devices
1–13 of 13
Cleared Jun 08, 2007
ARCHITECT I THEOPHYLLINE REAGENTS AND CALIBRATORS (A-F)
K070810
Biokit, S.A.
Toxicology · 74d
Cleared Aug 24, 1995
AXSYM THEOPHYLLINE II
K953016
Abbott Laboratories
Toxicology · 56d
Cleared Jun 20, 1995
CIBA CORINING ACS THEOPHYLLINE IMMUNOASSAY
K951169
Ciba Corning Diagnostics Corp.
Chemistry · 97d
Cleared Sep 09, 1994
QMS THEOPHYLLINE CS
K942991
Seradyn, Inc.
Toxicology · 81d
Cleared Aug 09, 1993
TDX/TDXFLX & TDXFLX THEOPHYLLINE MONOCLONAL II
K932127
Abbott Laboratories
Hematology · 98d
Cleared Aug 27, 1992
ABBOTT TDX/TDXFLX AND TDXFLX THEOPHYLLINE
K922991
Abbott Laboratories
Toxicology · 66d
Cleared Apr 12, 1990
MODIFIED ACCUFLUOR THEOPHYLLINE REAGENT & CALIBRA
K900706
Innotron of Oregon, Inc.
Toxicology · 59d
Cleared May 28, 1987
COBAS FP REAGENTS FOR THEOPHYLLINE & CALIBRATORS
K871484
Roche Diagnostic Systems, Inc.
Chemistry · 43d
Cleared Feb 18, 1987
MONITORX LASERX THEOPHYLLINE REAGENT SET
K870277
American Monitor Corp.
Toxicology · 22d
Cleared Feb 01, 1985
COBAS IMMUNOASSAY FOR THEOPHYLLINE & CAL
K843826
Roche Diagnostic Systems, Inc.
Toxicology · 126d

About Product Code LGS - Regulatory Context