LCR · Class II · 21 CFR 862.3900

FDA Product Code LCR: Fluorescent Immunoassay, Tobramycin

Leading manufacturers include Pb Diagnostic Systems, Inc., Beckman Instruments, Inc. and Dade Intl., Inc..

17
Total
17
Cleared
45d
Avg days
1980
Since

FDA 510(k) Cleared Fluorescent Immunoassay, Tobramycin Devices (Product Code LCR)

17 devices
1–17 of 17
Cleared Jul 21, 2006
QMS TOBRAMYCIN
K060998
Seradyn, Inc.
Chemistry · 101d
Cleared Sep 13, 1996
TOBRAMYCIN FLEX REAGENT CARTRIDGE
K962818
Dade Intl., Inc.
Toxicology · 56d
Cleared Aug 08, 1995
BECKMAN ARRAY TOBRAMYCIN (TOB) REAGENT
K952568
Beckman Instruments, Inc.
Toxicology · 64d
Cleared Jul 01, 1991
OPUS(R) TOBRAMYCIN
K911940
Pb Diagnostic Systems, Inc.
Toxicology · 61d
Cleared Jun 28, 1991
VAR AURAL GROM AG/S9,SD8.00.28.5/0.2 NS/S/6823 1.4
K911613
Exmoor Plastics , Ltd.
Toxicology · 86d
Cleared Jan 18, 1985
DU PONT TOBRAMYCIN ASSAY REAGENTS
K850058
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 10d
Cleared Aug 26, 1983
STRATUS TOBRAMYCIN FLUOROMETRIC ENZYM
K832408
American Dade
Chemistry · 36d
Cleared Aug 16, 1982
NEEDLE HOLDERS
K822197
Kelleher Corp.
Toxicology · 24d
Cleared Jun 03, 1982
VIRGO IMMUNO-PRECIPITATION ASSAY TOBRA
K821542
Electro-Nucleonics Laboratories, Inc.
Toxicology · 10d
Cleared Feb 05, 1982
ADVANCE SYSTEM EMIT-AMD TOBRAMYCIN ASSAY
K820130
Syva Co.
Toxicology · 18d
Cleared Jan 12, 1982
TOBRAMYCIN FLUORESCENT IMMUNOASSAY
K813542
American Diagnostic Corp.
Toxicology · 22d
Cleared Apr 17, 1981
AMES TDA TOBRAMYCIN TEST
K810941
Miles Laboratories, Inc.
Toxicology · 10d
Cleared Nov 24, 1980
CYBREX TOBRAMYCIN
K802668
Abbott Laboratories
Toxicology · 28d
Cleared Jun 20, 1980
FIAX TEST KIT FOR TOBRAMYCIN QUANTITA
K801308
Intl. Diagnostic Technology
Toxicology · 17d

About Product Code LCR - Regulatory Context