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
25–48 of 71
Cleared May 27, 1988
EZ-BEAD THEOPHYLLINE ENZYME IMMUNOASSAY KIT
K881257
Immunotech Corp.
Toxicology · 65d
Cleared Nov 24, 1987
EMIT CONVENIENCE PACK: THEOPHYLLINE ASSAY
K874578
Syva Co.
Chemistry · 18d
Cleared Apr 14, 1987
DART THEOPHYLLINE REAGENT SYSTEM
K870736
Coulter Electronics, Inc.
Toxicology · 48d
Cleared Mar 31, 1987
THEOPHYLLINE FPIA REAGENT SET
K870952
Sigma Diagnostics, Inc.
Toxicology · 21d
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 Dec 19, 1985
IN VITRO TEST DETERMINATION OF THEOPHYLLINE
K854183
Clinical Data, Inc.
Toxicology · 65d
Cleared Oct 15, 1985
VISION THEOPHYLLINE
K853834
Abbott Laboratories
Toxicology · 29d
Cleared Sep 04, 1985
GEMSTAR IPA THEOPHYLLINE TEST KIT
K853372
Electro-Nucleonics Laboratories, Inc.
Toxicology · 23d
Cleared Jul 12, 1985
TECHNICON RA-1000 SYSTEM ANALYTE THEOPHYLLINE
K852573
Technicon Instruments Corp.
Toxicology · 24d
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
Cleared Dec 11, 1984
THEOPHYLLINE RADIOIMMUNOASSAY ARIA HT SYSTEM
K844170
Bd Becton Dickinson Vacutainer Systems Preanalytic
Toxicology · 47d
Cleared May 22, 1984
DUPONT THEOPHYLLINE ASSAY KIT
K841656
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 29d
Cleared Mar 19, 1984
SERALYZER THEOPHYLLINE REAGENT STRIPS
K832825
Miles Laboratories, Inc.
Toxicology · 213d
Cleared Dec 30, 1983
STRATUS THEOPHYLLINE ASSAY
K832965
American Dade
Chemistry · 120d
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