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
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times increasing: avg 239d recently vs 64d historically

FDA 510(k) Cleared Enzyme Immunoassay, Gentamicin Devices (Product Code LCD)

37 devices
1–24 of 37
Cleared Jul 09, 2025
ARCHITECT iGentamicin
K243500
Abbott Laboratories
Toxicology · 239d
Cleared Apr 01, 2011
ARCHITECT IGENTAMICIN REAGENTS
K102699
Abbott Laboratories
Toxicology · 193d
Cleared Jan 06, 2005
VITROS CHEMISTRY PRODUCTS GENT, TOBRA & VANC REAGENTS
K042479
Ortho-Clinical Diagnostics, Inc.
Toxicology · 115d
Cleared Jul 12, 2002
ROCHE ONLINE GENTAMICIN
K020704
Roche Diagnostics Corp.
Toxicology · 130d
Cleared Sep 18, 2001
RANDOX GENTAMICIN
K012978
Randox Laboratories, Ltd.
Toxicology · 74d
Cleared Aug 20, 2001
IMMULITE 2000 GENTAMICIN, MODELS L2KGE2 (200 TESTS), L2KGE6 (600 TESTS)
K012311
Diagnostic Products Corp.
Chemistry · 28d
Cleared Sep 04, 1996
EMIT 2000 GENTAMICIN ASSAY AND CALIBRATORS
K962519
Behring Diagnostics, Inc.
Toxicology · 69d
Cleared Aug 02, 1995
ACS GENTAMICIN
K953020
Ciba Corning Diagnostics Corp.
Toxicology · 34d
Cleared Jan 25, 1995
IL TEST GENTAMICIN CALIBRATORS
K943982
Instrumentation Laboratory CO
Toxicology · 232d
Cleared Sep 27, 1991
CEDIA(R) GENTAMICIN ASSAY
K913470
Microgenics Corp.
Toxicology · 53d
Cleared Oct 15, 1990
DUPONT DIMENSION(R) GENTAMICIN(GENT) METHOD
K904305
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 26d
Cleared Sep 17, 1990
IL GENTAMICIN ASSAY SYSTEM
K903743
Instrumentation Laboratory CO
Toxicology · 32d
Cleared Oct 04, 1989
STRATUS(R) GENTAMICIN FLUOROMETRIC ENZYME IMMUNO.
K895484
Baxter Healthcare Corp
Toxicology · 23d
Cleared Aug 21, 1989
TECHNICON RA SYSTEMS GENTAMICIN TEST METHOD
K893912
Technicon Instruments Corp.
Toxicology · 83d
Cleared Dec 18, 1987
EMIT CONVENIENCE PACK: GENTAMICIN ASSAY
K874703
Syva Co.
Toxicology · 32d
Cleared Oct 29, 1987
EMIT QST GENTAMICIN ASSAY
K873855
Syva Co.
Toxicology · 37d
Cleared Oct 28, 1987
EMIT GENTAMICIN ASSAY
K873854
Syva Co.
Toxicology · 36d
Cleared May 12, 1987
EASY-TEST EMIT GENTAMICIN (GENT) ITEM NO. 16640
K871329
Em Diagnostic Systems, Inc.
Toxicology · 39d
Cleared Nov 03, 1986
EMIT CHLORAMPHENICOL ASSAY/BI-LEVEL CONTROLS
K862260
Syva Co.
Toxicology · 143d
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

About Product Code LCD - Regulatory Context

510(k) Submission Activity

37 total 510(k) submissions under product code LCD since 1980, with 37 receiving FDA clearance (average review time: 69 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - LCD Product Code

Recent submissions under LCD have taken an average of 239 days to reach a decision - up from 64 days historically. Manufacturers should account for longer review timelines in current project planning.

LCD devices are reviewed by the Toxicology panel. Browse all Toxicology devices →