Panels › Clinical Toxicology › Product code LCD · Class 2
Enzyme Immunoassay, Gentamicin
Regulation 862.3450
0510(k)s in 12 months (37 all time)
0recalls in 12 months (13 all time)
11recalls that name a 510(k)
Top companies in LCD
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 9, 2025 | K243500 | ARCHITECT iGentamicin Abbott Laboratories | LCD |
| Apr 1, 2011 | K102699 | ARCHITECT IGENTAMICIN REAGENTS; ARCHITECT IGENTAMICIN CALIBRATORS Abbott Laboratories | LCD |
| Jun 15, 2006 | K060709 | MULTIGENT GENTAMICIN Seradyn, Inc. | LCD |
| Jan 6, 2005 | K042479 | VITROS CHEMISTRY PRODUCTS GENT, TOBRA & VANC REAGENTS; VITROS CHEMISTYR PRODUCTS CALIBRATOR KITS 11, 13 & 14; VITROS CHE Ortho-Clinical Diagnostics, Inc. | LCD |
| Jul 12, 2002 | K020704 | ROCHE ONLINE GENTAMICIN Roche Diagnostics Corp. | LCD |
| Sep 18, 2001 | K012978 | RANDOX GENTAMICIN Randox Laboratories, Ltd., IE | LCD |
| Aug 20, 2001 | K012311 | IMMULITE 2000 GENTAMICIN, MODELS L2KGE2 (200 TESTS), L2KGE6 (600 TESTS) Diagnostic Products Corp. | LCD |
| Apr 20, 2001 | K010984 | EMIT 2000 GENTAMICIN PLUS ASSAY Syva Co., Dade Behring, Inc. | LCD |
| Sep 13, 1996 | K962819 | GENTAMICIN FLEX REAGENT CARTRIDGE Dade Intl., Inc. | LCD |
| Sep 4, 1996 | K962519 | EMIT 2000 GENTAMICIN ASSAY AND CALIBRATORS Behring Diagnostics, Inc. | LCD |
| Aug 2, 1995 | K953020 | ACS GENTAMICIN Ciba Corning Diagnostics Corp. | LCD |
| Jan 25, 1995 | K943982 | IL TEST GENTAMICIN CALIBRATORS Instrumentation Laboratory CO | LCD |
| Jun 21, 1994 | K935376 | AXSYM GENTAMICIN Abbott Mfg., Inc. | LCD |
| Jun 2, 1994 | K940376 | QMS GENTAMICIN ASSAY Seradyn, Inc. | LCD |
| Sep 27, 1991 | K913470 | CEDIA(R) GENTAMICIN ASSAY Microgenics Corp. | LCD |
| Oct 15, 1990 | K904305 | DUPONT DIMENSION(R) GENTAMICIN(GENT) METHOD E.I. Dupont DE Nemours & Co., Inc. | LCD |
| Sep 17, 1990 | K903743 | IL GENTAMICIN ASSAY SYSTEM Instrumentation Laboratory CO | LCD |
| Apr 12, 1990 | K900703 | MODIFIED ACCUFLUOR GENTAMICIN REAGENT & CALIBRATOR Innotron of Oregon, Inc. | LCD |
| Oct 4, 1989 | K895484 | STRATUS(R) GENTAMICIN FLUOROMETRIC ENZYME IMMUNO. Baxter Healthcare Corp | LCD |
| Aug 21, 1989 | K893912 | TECHNICON RA SYSTEMS GENTAMICIN TEST METHOD Technicon Instruments Corp. | LCD |
| Dec 18, 1987 | K874703 | EMIT CONVENIENCE PACK: GENTAMICIN ASSAY Syva Co. | LCD |
| Oct 29, 1987 | K873855 | EMIT QST GENTAMICIN ASSAY Syva Co. | LCD |
| Oct 28, 1987 | K873854 | EMIT GENTAMICIN ASSAY Syva Co. | LCD |
| May 12, 1987 | K871329 | EASY-TEST EMIT GENTAMICIN (GENT) ITEM NO. 16640 Em Diagnostic Systems, Inc. | LCD |
| Nov 3, 1986 | K862260 | EMIT CHLORAMPHENICOL ASSAY/BI-LEVEL CONTROLS Syva Co. | LCD |
| Apr 3, 1986 | K860868 | TECHNICON RA SYSTEMS/TOBRAMYCIN & GENTAMICIN Technicon Instruments Corp. | LCD |
| Jan 22, 1986 | K860045 | DETERMINATION OF GENTAMICIN Clinical Data, Inc. | LCD |
| Aug 2, 1985 | K852672 | ACA GENTAMICIN TEST PACK E.I. Dupont DE Nemours & Co., Inc. | LCD |
| Jan 18, 1985 | K850060 | DU PONT GENTAMICIN ASSAY REAGENTS E.I. Dupont DE Nemours & Co., Inc. | LCD |
| Aug 31, 1983 | K832445 | STRATUS GENTAMICIN FLUOROMETRIC ENZYM American Dade | LCD |
| Aug 8, 1983 | K832056 | EMIT AMD GENTAMICIN ASSAY Syva Co. | LCD |
| Jun 8, 1983 | K831416 | EMIT QST TOBRAMYCIN ASSAY Syva Co. | LCD |
| Jun 2, 1983 | K831304 | EMIT QST GENTAMICIN ASSAY Syva Co. | LCD |
| Dec 22, 1982 | K823387 | SOPHEIA GENTAMICIN EIA KIT Diagnostic Products Corp. | LCD |
| Jul 15, 1981 | K811692 | GENTAMICIN REAGENT TEST KIT Beckman Instruments, Inc. | LCD |
| Jul 10, 1981 | K811744 | VIRGO IPA FOR DETECTION OF GENTAMICIN Electro-Nucleonics Laboratories, Inc. | LCD |
| Feb 5, 1980 | K800150 | EMIT TOBRAMYCIN ASSAY Syva Co. | LCD |
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