KLS · Class II · 21 CFR 862.3880

FDA Product Code KLS: Enzyme Immunoassay, Theophylline

Leading manufacturers include Syva Co., Abbott Laboratories and E.I. Dupont DE Nemours & Co., Inc..

71
Total
71
Cleared
69d
Avg days
1978
Since

FDA 510(k) Cleared Enzyme Immunoassay, Theophylline Devices (Product Code KLS)

71 devices
1–24 of 71
Cleared Nov 30, 2004
VITROS CHEMISTRY PRODUCTS CAFFN REAGENT KIT AND TDM PERFORMANCE VERIFIERS I, II AND III
K042520
Ortho-Clinical Diagnostics, Inc.
Toxicology · 75d
Cleared Oct 28, 2004
EMIT CAFFEINE ASSAY
K042407
Dade Behring, Inc.
Toxicology · 55d
Cleared Apr 16, 2002
ROCHE ONLINE THEOPHYLLINE
K020740
Roche Diagnostics Corp.
Toxicology · 41d
Cleared Jan 17, 2002
RANDOX THEOPHYLLINE
K011771
Randox Laboratories, Ltd.
Chemistry · 225d
Cleared Oct 25, 2001
ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAY
K013272
Bayer Corp.
Chemistry · 24d
Cleared Jan 27, 2000
ABBOTT AEROSET THEOPHYLLINE ASSAY AND CALIBRATORS
K993029
Syva Co.
Toxicology · 140d
Cleared Jun 27, 1996
CEDIA THEOPHYLLINE ASSAY
K961462
Boehringer Mannheim Corp.
Toxicology · 71d
Cleared Nov 13, 1995
IMMULITE THEOPHYLLINE
K954569
Diagnostic Products Corp.
Toxicology · 42d
Cleared Aug 11, 1995
THEOPHYLLINE ENZYME IMMUNOASSAY
K952596
Diagnostic Reagents, Inc.
Toxicology · 66d
Cleared Jan 18, 1995
IL TEST THEOPHYLLINE
K943979
Instrumentation Laboratory CO
Toxicology · 225d
Cleared Jun 21, 1994
AXSYM THEOPHYLLINE
K935373
Abbott Laboratories
Toxicology · 225d
Cleared Sep 24, 1993
PARAMAX(R) THEOPHYLLINE REAGENT AND CALIBRATORS
K932685
Baxter Diagnostics, Inc.
Toxicology · 113d
Cleared Aug 16, 1993
VIDAS THEOPHYLLINE(THEO)
K933258
Biomerieux Vitek, Inc.
Toxicology · 41d
Cleared May 06, 1993
ABBOTT VISION THEOPHYLLINE IIA
K926245
Abbott Laboratories
Toxicology · 143d
Cleared Sep 19, 1991
EMIT(R) 2000 THEOPHYLLINE ASSAY/CALIBRATORS
K913123
Syva Co.
Toxicology · 66d
Cleared Apr 03, 1991
IL THEOPHYLLINE ASSAY SYSTEM
K910697
Instrumentation Laboratory CO
Chemistry · 43d
Cleared Jul 05, 1990
TECHNICON IMMUNO I(TM) SYSTEM AND ANALYTES
K902243
Technicon Instruments Corp.
Chemistry · 48d
Cleared Jun 12, 1990
ENZYMATIC THEOPHYLLINE REAGENT, #500-82
K901510
Diagnostic Chemicals, Ltd. (Usa)
Toxicology · 74d
Cleared Mar 29, 1990
NDS THEOPHYLLINE TEST KIT & NDS TDM CALIBRATOR SET
K900009
Kallestad Diag, A Div. of Erbamont, Inc.
Toxicology · 86d
Cleared Jan 18, 1990
VISION THEOPHYLLINE II
K896927
Abbott Laboratories
Toxicology · 37d
Cleared Mar 31, 1989
ACCULEVEL ONE-STEP THEOPHYLLINE TEST
K885253
Syva Co.
Chemistry · 98d
Cleared Feb 07, 1989
CEDIA THEOPHYLLINE ASSAY
K884358
Microgenics Corp.
Toxicology · 113d
Cleared Jan 23, 1989
COAT-A-COUNT (TM) THEOPHYLLINE
K890002
Diagnostic Products Corp.
Toxicology · 20d
Cleared Dec 29, 1988
BEHRING POLAROID OPUS THEOPHYLLINE
K885044
Pb Diagnostic Systems, Inc.
Toxicology · 24d

About Product Code KLS - Regulatory Context