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
71 devices
49–71 of 71
Cleared Dec 27, 1983
CHEM KIT THEOPHYLLINE DIAG. KIT
K833683
Abbott Laboratories
Toxicology · 57d
Cleared Sep 12, 1983
THEOPHYLLINE TEST PACK ACA
K831934
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 89d
Cleared Aug 01, 1983
EMIT AAD THEOPHYLLINE ASSAY
K832034
Syva Co.
Chemistry · 39d
Cleared May 27, 1983
EMIT QST THEOPHYLLINE ASSAY
K831272
Syva Co.
Chemistry · 38d
Cleared Jun 10, 1982
DETECTION OF THEOPHYLLINE
K821544
Electro-Nucleonics Laboratories, Inc.
Toxicology · 17d
Cleared Jul 27, 1981
A-GENT THEOPHYLLINE
K812003
Abbott Laboratories
Chemistry · 13d
Cleared Mar 13, 1981
BECKMAN THEOPHYLLINE REAGENT TEST KIT
K810578
Beckman Instruments, Inc.
Toxicology · 10d
Cleared Mar 06, 1981
COPPER SULFATE SOLUTION SP. GR.1.053
K803094
Accra Laboratories, Inc.
Hematology · 88d
Cleared Oct 23, 1980
ENDAB THEOPHYLLINE ENZYME IMMUNOASSAY
K802066
Immunotech Corp.
Immunology · 57d
Cleared Aug 27, 1980
FIAX TEST KIT FOR THEOPHYLLINE QUANT.
K801642
Intl. Diagnostic Technology
Toxicology · 41d
Cleared Jul 08, 1980
APPLICATION OF EMIT THEOPHYLLINE ASSAY
K801476
Syva Co.
Toxicology · 14d
Cleared Apr 10, 1980
AMES TDA THEOPHYL-LINE TEST
K800646
Miles Laboratories, Inc.
Toxicology · 17d
Cleared Mar 02, 1979
EMIT THEOPHYLLINE ASSAY
K790256
Syva Co.
Toxicology · 24d
Cleared Mar 27, 1978
IN VITRO THEOPHYLLINE RIA TEST
K772017
Clinical Assays, Inc.
Immunology · 152d