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LFM — Enzyme Immunoassay, Digitoxin Class II

FDA Device Classification

Classification Details

Product Code
LFM
Device Class
Class II
Regulation Number
862.3300
Submission Type
Review Panel
TX
Medical Specialty
Clinical Toxicology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K062024dade behringDIMENSION VISTA DIGITOXIN, DIGOXIN, GENTAMICIN, N-ACETYLPROCAINAMIDE, PHENYTOIN,July 28, 2006
K012112randox laboratoriesRANDOX DIGITOXINJanuary 11, 2002
K990251dade behringDGTX FLEX REAGENT CARTRIDGE, MODEL DF36March 31, 1999
K970546chiron diagnosticsACS DIGITOXINJuly 14, 1997
K963158abbott laboratoriesABBOTT AXSYM DIGITOXIN (MODIFY)September 10, 1996
K954420abbott laboratoriesAXSYM DIGITOXINDecember 29, 1995
K951631bayerDIGOXIN ASSAY FOR THE TECCHNICON RA/OPERA SYSTEMS IN-VITRO DIAGNOSTIC SYSTEMSJune 9, 1995
K943235diagnostic productsIMMULITE DIGITOXINOctober 27, 1994
K942610eastman kodakKODAK EXTACHEM CLINICAL CHEMISTRY SLIDE DIGOXIN (DGXN)October 20, 1994
K942619syvaEMIT 2000 DIGOXIN ASSAY/CALIBRATORSSeptember 20, 1994
K915465sigma diagnosticsDIGITOXIN FPIA REAGENT SETJanuary 27, 1992
K913187intl. bioclinicalINNOFLUOR(TM) DIGITOXIN REAGENT SETSeptember 23, 1991
K913240tudor laboratoriesDIGITOXIN (FPIA) KITSeptember 6, 1991
K900013diagnostic productsMILENIA (TM) DIGITOXINMarch 9, 1990
K896021microgenicsCEDIA DIGITOXIN ASSAYNovember 8, 1989
K891094e.i. dupont de nemours and coACA(R) DIGITOXIN (DGTX) METHODApril 26, 1989
K862067american dadeSTRATUS DIGITOXIN FLUOROMETRIC ENZYME IMMUNOASSAYJune 16, 1986
K842280abbott laboratoriesTDX DIGITOXINAugust 16, 1984
K842578diagnostic productsSOPHEIA/MP DIGITOXIN EIA KITAugust 12, 1984
K830035diagnostic productsSOPHEIA DIGITOXIN EIA KIT & COMPONENTSJanuary 28, 1983