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 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 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 Jan 18, 1995
IL TEST THEOPHYLLINE
K943979
Instrumentation Laboratory CO
Toxicology · 225d
Cleared Jun 21, 1994
AXSYM THEOPHYLLINE
K935373
Abbott Laboratories
Toxicology · 225d
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 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 Jan 23, 1989
COAT-A-COUNT (TM) THEOPHYLLINE
K890002
Diagnostic Products Corp.
Toxicology · 20d
Cleared Nov 24, 1987
EMIT CONVENIENCE PACK: THEOPHYLLINE ASSAY
K874578
Syva Co.
Chemistry · 18d
Cleared Nov 25, 1986
EMDS THEOPHYLLINE TESTPACKS ITEM #67662/95
K864041
Em Diagnostic Systems, Inc.
Toxicology · 40d
Cleared Sep 25, 1986
METHODS FOR THE DIMENSION CLINICAL CHEM. SYSTEM
K862955
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 51d
Cleared Jul 07, 1986
EASY-TEST EMIT* THEOPHYLLINE(THEO) ITEM 67533/93
K862350
Em Diagnostic Systems, Inc.
Toxicology · 17d
Cleared Jun 17, 1986
VISION THEOPHYLLINE - ADDIT. OF WHOLE BLOOD CLAIM
K860464
Abbott Laboratories
Toxicology · 131d
Cleared Jun 13, 1986
EMIT CAFFEINE ASSAY
K853872
Syva Co.
Toxicology · 269d
Cleared May 29, 1986
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (THEO)
K861367
Eastman Kodak Company
Chemistry · 48d
Cleared Oct 15, 1985
VISION THEOPHYLLINE
K853834
Abbott Laboratories
Toxicology · 29d
Cleared Jun 06, 1985
ACCULEVEL THEOPHYLLINE TEST(MODIFICATION)
K851741
Syva Co.
Toxicology · 38d
Cleared Mar 29, 1985
ICS THEOPHYLLINE REAGENTS
K850856
Beckman Instruments, Inc.
Chemistry · 28d
Cleared Mar 19, 1985
ACCULEVEL THEOPHYLLINE TEST
K844642
Syva Co.
Immunology · 111d

About Product Code KLS - Regulatory Context