LCQ · Class II · 21 CFR 862.3450

FDA Product Code LCQ: Fluorescent Immunoassay Gentamicin

Leading manufacturers include Roche Diagnostic Systems, Inc., Abbott Laboratories and Syva Co..

19
Total
19
Cleared
48d
Avg days
1979
Since

FDA 510(k) Cleared Fluorescent Immunoassay Gentamicin Devices (Product Code LCQ)

19 devices
1–19 of 19
Cleared Aug 06, 1997
VARIANT EXPRESS GLYCOHEMOGLOBIN PROGRAM
K972609
Bio-Rad
Hematology · 26d
Cleared Mar 09, 1995
COBAS(R)-FP REAGENTS FOR GENTAMICIN AND COBAS(R)-FP GENTAMICIN CALIBRATORS
K945523
Roche Diagnostic Systems, Inc.
Toxicology · 119d
Cleared Nov 17, 1994
GENTAMICIN FPIA REAGENT SET AND CALIBRATORS
K943550
Sigma Diagnostics, Inc.
Toxicology · 119d
Cleared Feb 21, 1991
OPUS GENTAMICIN
K905721
Pb Diagnostic Systems, Inc.
Toxicology · 62d
Cleared Oct 29, 1990
'TDXFLX ANALYZER
K904226
Abbott Laboratories
Chemistry · 46d
Cleared Feb 01, 1985
COBAS REAGENTS FOR GENTAMICIN & CALIBRAT
K843827
Roche Diagnostic Systems, Inc.
Toxicology · 126d
Cleared Feb 18, 1982
SYVA ADVANCE SYST. EMIT-AMD GENT. ASSAY
K820285
Syva Co.
Toxicology · 16d
Cleared Dec 31, 1981
GENTAMICIN FLUORESCENT IMMUNOASSAY
K813539
American Diagnostic Corp.
Toxicology · 10d
Cleared Apr 17, 1981
AMES TDA GENTAMICIN TEST
K810942
Miles Laboratories, Inc.
Toxicology · 10d
Cleared May 23, 1980
CYBREX GENTAMICIN
K801084
Abbott Laboratories
Toxicology · 16d
Cleared Jan 23, 1980
FIAX TEST KIT FOR GENTAMICIN QUAN.
K800032
Intl. Diagnostic Technology
Toxicology · 16d

About Product Code LCQ - Regulatory Context