FDA 510(k) Applications for Medical Device Product Code "LBZ"
(Enzyme Immunoassay, Quinidine)

FDA 510(k) Number Applicant Device Name Decision Date
K842713 ABBOTT LABORATORIES TDX DISOPYRAMIDE 08/29/1984
K822653 ABBOTT LABORATORIES TDX QUINIDINE 09/28/1982
K872175 ABBOTT LABORATORIES TDXR FLECAINIDE 08/13/1987
K843237 AMERICAN DADE STRATUS QUINIDINE FLUOROMETRIC ENZYME 09/12/1984
K832493 AMERICAN DIAGNOSTIC CORP. QUINIDINE FLUORESCENT IMMUNOASSAY 09/12/1983
K964116 BAYER CORP. QUINIDINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) 12/24/1996
K830963 BECKMAN INSTRUMENTS, INC. QUINIDINE REAGENT TEST KIT 06/30/1983
K860049 CLINICAL DATA, INC. DETERMINATION OF QUINIDINE 01/22/1986
K964212 DIAGNOSTIC REAGENTS, INC. QUINIDINE ENZYME IMMUNOASSAY 12/18/1996
K840596 E.I. DUPONT DE NEMOURS & CO., INC. QUINIDINE ANALYTICAL TEST PACK 04/04/1984
K864607 EM DIAGNOSTIC SYSTEMS, INC. EASY-TEST QUINIDINE ITEM NO. 67---/95 01/08/1987
K892208 INNOTRON OF OREGON, INC. INNOFLUOR(TM) QUINIDINE REAGENT SET 06/09/1989
K900705 INNOTRON OF OREGON, INC. MODIFIED ACCUFLUOR QUINIDINE REAGENT & CALIBRATOR 04/12/1990
K812753 MILES LABORATORIES, INC. AMES TDA QUINIDINE TEST 10/19/1981
K955568 OXIS INTL., INC. INNOFLUOR QUINIDINE ASSAY SYSTEM 04/04/1996
K850808 ROCHE DIAGNOSTIC SYSTEMS, INC. COBAS FP REAGENTS FOR QUINIDINE 03/25/1985
K941440 ROCHE DIAGNOSTIC SYSTEMS, INC. COBAS-FP QUINIDINE REAGENTS AND CALIBRATORS 07/06/1994
K032332 ROCHE DIAGNOSTICS CORP. ROCHE ONLINE TDM QUINIDINE 01/12/2004
K052826 SERADYN INC. QMS QUINIDINE. QMS QUINIDINE CALIBRATORS 12/23/2005
K822588 SYVA CO. ADVANCE EMIT-CAD QUINIDINE ASSAY 09/17/1982
K922913 SYVA CO. EMIT 2000 QUINDINE ASSAY QUIDIDINE CALIBRATORS 08/24/1992
K832096 SYVA CO. EMIT CAD QUINIDINE ASSAY FOR USE W/ 08/08/1983
K904990 SYVA CO. EMIT CONVENIENCE PACK, QUINIDINE ASSAY/CALIBRATORS 02/04/1991
K831355 SYVA CO. EMIT QST QUINIDINE ASSAY 06/02/1983
K862214 SYVA CO. EMIT QUINIDINE ASSAY 06/27/1986
K811460 SYVA CO. EMIT-CAD QUINIDINE ASSAY 06/09/1981
K011605 SYVA CO., DADE BEHRING, INC. EMIT 2000 QUINIDINE ASSAY, MODEL OSR4Q229 06/12/2001


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