LCD · Class II · 21 CFR 862.3450

FDA Product Code LCD: Enzyme Immunoassay, Gentamicin

Leading manufacturers include Syva Co., E.I. Dupont DE Nemours & Co., Inc. and Diagnostic Products Corp..

37
Total
37
Cleared
69d
Avg days
1980
Since
37 devices
25–37 of 37
Cleared Apr 03, 1986
TECHNICON RA SYSTEMS/TOBRAMYCIN & GENTAMICIN
K860868
Technicon Instruments Corp.
Chemistry · 27d
Cleared Jan 22, 1986
DETERMINATION OF GENTAMICIN
K860045
Clinical Data, Inc.
Toxicology · 16d
Cleared Aug 02, 1985
ACA GENTAMICIN TEST PACK
K852672
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 39d
Cleared Jan 18, 1985
DU PONT GENTAMICIN ASSAY REAGENTS
K850060
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 10d
Cleared Aug 31, 1983
STRATUS GENTAMICIN FLUOROMETRIC ENZYM
K832445
American Dade
Chemistry · 37d
Cleared Aug 08, 1983
EMIT AMD GENTAMICIN ASSAY
K832056
Syva Co.
Chemistry · 42d
Cleared Jun 08, 1983
EMIT QST TOBRAMYCIN ASSAY
K831416
Syva Co.
Toxicology · 36d
Cleared Jun 02, 1983
EMIT QST GENTAMICIN ASSAY
K831304
Syva Co.
Immunology · 42d
Cleared Dec 22, 1982
SOPHEIA GENTAMICIN EIA KIT
K823387
Diagnostic Products Corp.
Chemistry · 37d
Cleared Jul 15, 1981
GENTAMICIN REAGENT TEST KIT
K811692
Beckman Instruments, Inc.
Toxicology · 30d
Cleared Jul 10, 1981
VIRGO IPA FOR DETECTION OF GENTAMICIN
K811744
Electro-Nucleonics Laboratories, Inc.
Toxicology · 21d
Cleared Feb 05, 1980
EMIT TOBRAMYCIN ASSAY
K800150
Syva Co.
Toxicology · 14d