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LBZ — Enzyme Immunoassay, Quinidine Class II

FDA Device Classification

Classification Details

Product Code
LBZ
Device Class
Class II
Regulation Number
862.3320
Submission Type
Review Panel
TX
Medical Specialty
Clinical Toxicology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K052826seradynQMS QUINIDINE. QMS QUINIDINE CALIBRATORSDecember 23, 2005
K032332roche diagnosticsROCHE ONLINE TDM QUINIDINEJanuary 12, 2004
K011605syva co., dade behringEMIT 2000 QUINIDINE ASSAY, MODEL OSR4Q229June 12, 2001
K964116bayerQUINIDINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)December 24, 1996
K964212diagnostic reagentsQUINIDINE ENZYME IMMUNOASSAYDecember 18, 1996
K955568oxis intlINNOFLUOR QUINIDINE ASSAY SYSTEMApril 4, 1996
K941440roche diagnostic systemsCOBAS-FP QUINIDINE REAGENTS AND CALIBRATORSJuly 6, 1994
K922913syvaEMIT 2000 QUINDINE ASSAY QUIDIDINE CALIBRATORSAugust 24, 1992
K904990syvaEMIT CONVENIENCE PACK, QUINIDINE ASSAY/CALIBRATORSFebruary 4, 1991
K900705innotron of oregonMODIFIED ACCUFLUOR QUINIDINE REAGENT & CALIBRATORApril 12, 1990
K892208innotron of oregonINNOFLUOR(TM) QUINIDINE REAGENT SETJune 9, 1989
K872175abbott laboratoriesTDXR FLECAINIDEAugust 13, 1987
K864607em diagnostic systemsEASY-TEST QUINIDINE ITEM NO. 67---/95January 8, 1987
K862214syvaEMIT QUINIDINE ASSAYJune 27, 1986
K860049clinical dataDETERMINATION OF QUINIDINEJanuary 22, 1986
K850808roche diagnostic systemsCOBAS FP REAGENTS FOR QUINIDINEMarch 25, 1985
K843237american dadeSTRATUS QUINIDINE FLUOROMETRIC ENZYMESeptember 12, 1984
K842713abbott laboratoriesTDX DISOPYRAMIDEAugust 29, 1984
K840596e.i. dupont de nemours and coQUINIDINE ANALYTICAL TEST PACKApril 4, 1984
K832493american diagnosticQUINIDINE FLUORESCENT IMMUNOASSAYSeptember 12, 1983