Product code LCD— Clinical Toxicology

FDA has cleared 37 devices under product code LCD between 1980 and 2025, filed by 23 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20251 clearance
• 20111 clearance
• 20061 clearance
• 20051 clearance
• 20021 clearance
• 20013 clearances
• 19962 clearances
• 19952 clearances
• 19942 clearances
• 19911 clearance
• 19903 clearances
• 19892 clearances
• 19874 clearances
• 19863 clearances
• 19852 clearances

• Syva Co.8 clearances
• E.I. Dupont DE Nemours & Co., Inc.3 clearances
• Technicon Instruments Corp.2 clearances
• Seradyn, Inc.2 clearances
• Instrumentation Laboratory CO2 clearances
• Diagnostic Products Corp.2 clearances
• Abbott Laboratories2 clearances
• Syva Co., Dade Behring, Inc.1 clearance
• Roche Diagnostics Corp.1 clearance
• Randox Laboratories, Ltd.1 clearance

• K243500 — ARCHITECT iGentamicinAbbott Laboratories·2025-07-09
• K102699 — ARCHITECT IGENTAMICIN REAGENTS; ARCHITECT IGENTAMICIN CALIBRATORSAbbott Laboratories·2011-04-01
• K060709 — MULTIGENT GENTAMICINSeradyn, Inc.·2006-06-15
• K042479 — VITROS CHEMISTRY PRODUCTS GENT, TOBRA & VANC REAGENTS; VITROS CHEMISTYR PRODUCTS CALIBRATOR KITS 11, 13 & 14Ortho-Clinical Diagnostics, Inc.·2005-01-06
• K020704 — ROCHE ONLINE GENTAMICINRoche Diagnostics Corp.·2002-07-12
• K012978 — RANDOX GENTAMICINRandox Laboratories, Ltd.·2001-09-18
• K012311 — IMMULITE 2000 GENTAMICIN, MODELS L2KGE2 (200 TESTS), L2KGE6 (600 TESTS)Diagnostic Products Corp.·2001-08-20
• K010984 — EMIT 2000 GENTAMICIN PLUS ASSAYSyva Co., Dade Behring, Inc.·2001-04-20
• K962819 — GENTAMICIN FLEX REAGENT CARTRIDGEDade Intl., Inc.·1996-09-13
• K962519 — EMIT 2000 GENTAMICIN ASSAY AND CALIBRATORSBehring Diagnostics, Inc.·1996-09-04
• K953020 — ACS GENTAMICINCiba Corning Diagnostics Corp.·1995-08-02
• K943982 — IL TEST GENTAMICIN CALIBRATORSInstrumentation Laboratory CO·1995-01-25
• K935376 — AXSYM GENTAMICINAbbott Mfg., Inc.·1994-06-21
• K940376 — QMS GENTAMICIN ASSAYSeradyn, Inc.·1994-06-02
• K913470 — CEDIA(R) GENTAMICIN ASSAYMicrogenics Corp.·1991-09-27
• K904305 — DUPONT DIMENSION(R) GENTAMICIN(GENT) METHODE.I. Dupont DE Nemours & Co., Inc.·1990-10-15
• K903743 — IL GENTAMICIN ASSAY SYSTEMInstrumentation Laboratory CO·1990-09-17
• K900703 — MODIFIED ACCUFLUOR GENTAMICIN REAGENT & CALIBRATORInnotron of Oregon, Inc.·1990-04-12
• K895484 — STRATUS(R) GENTAMICIN FLUOROMETRIC ENZYME IMMUNO.Baxter Healthcare Corp·1989-10-04
• K893912 — TECHNICON RA SYSTEMS GENTAMICIN TEST METHODTechnicon Instruments Corp.·1989-08-21
• K874703 — EMIT CONVENIENCE PACK: GENTAMICIN ASSAYSyva Co.·1987-12-18
• K873855 — EMIT QST GENTAMICIN ASSAYSyva Co.·1987-10-29
• K873854 — EMIT GENTAMICIN ASSAYSyva Co.·1987-10-28
• K871329 — EASY-TEST EMIT GENTAMICIN (GENT) ITEM NO. 16640Em Diagnostic Systems, Inc.·1987-05-12
• K862260 — EMIT CHLORAMPHENICOL ASSAY/BI-LEVEL CONTROLSSyva Co.·1986-11-03
• K860868 — TECHNICON RA SYSTEMS/TOBRAMYCIN & GENTAMICINTechnicon Instruments Corp.·1986-04-03
• K860045 — DETERMINATION OF GENTAMICINClinical Data, Inc.·1986-01-22
• K852672 — ACA GENTAMICIN TEST PACKE.I. Dupont DE Nemours & Co., Inc.·1985-08-02
• K850060 — DU PONT GENTAMICIN ASSAY REAGENTSE.I. Dupont DE Nemours & Co., Inc.·1985-01-18
• K832445 — STRATUS GENTAMICIN FLUOROMETRIC ENZYMAmerican Dade·1983-08-31
• K832056 — EMIT AMD GENTAMICIN ASSAYSyva Co.·1983-08-08
• K831416 — EMIT QST TOBRAMYCIN ASSAYSyva Co.·1983-06-08
• K831304 — EMIT QST GENTAMICIN ASSAYSyva Co.·1983-06-02
• K823387 — SOPHEIA GENTAMICIN EIA KITDiagnostic Products Corp.·1982-12-22
• K811692 — GENTAMICIN REAGENT TEST KITBeckman Instruments, Inc.·1981-07-15
• K811744 — VIRGO IPA FOR DETECTION OF GENTAMICINElectro-Nucleonics Laboratories, Inc.·1981-07-10
• K800150 — EMIT TOBRAMYCIN ASSAYSyva Co.·1980-02-05