FDA Product Code LBZ: Enzyme Immunoassay, Quinidine
Leading manufacturers include Syva Co., Abbott Laboratories and Roche Diagnostic Systems, Inc..
27
Total
27
Cleared
55d
Avg days
1981
Since
FDA 510(k) Cleared Enzyme Immunoassay, Quinidine Devices (Product Code LBZ)
27 devices
Cleared
Jan 12, 2004
ROCHE ONLINE TDM QUINIDINE
Roche Diagnostics Corp.
Toxicology
167d
Cleared
Jul 06, 1994
COBAS-FP QUINIDINE REAGENTS AND CALIBRATORS
Roche Diagnostic Systems, Inc.
Toxicology
104d
Cleared
Aug 24, 1992
EMIT 2000 QUINDINE ASSAY QUIDIDINE CALIBRATORS
Syva Co.
Chemistry
68d
Cleared
Feb 04, 1991
EMIT CONVENIENCE PACK, QUINIDINE ASSAY/CALIBRATORS
Syva Co.
Toxicology
90d
Cleared
Aug 13, 1987
TDXR FLECAINIDE
Abbott Laboratories
Chemistry
66d
Cleared
Jan 08, 1987
EASY-TEST QUINIDINE ITEM NO. 67---/95
Em Diagnostic Systems, Inc.
Toxicology
45d
Cleared
Jun 27, 1986
EMIT QUINIDINE ASSAY
Syva Co.
Toxicology
17d
Cleared
Mar 25, 1985
COBAS FP REAGENTS FOR QUINIDINE
Roche Diagnostic Systems, Inc.
Toxicology
26d
Cleared
Aug 29, 1984
TDX DISOPYRAMIDE
Abbott Laboratories
Chemistry
48d
Cleared
Apr 04, 1984
QUINIDINE ANALYTICAL TEST PACK
E.I. Dupont DE Nemours & Co., Inc.
Toxicology
55d
Cleared
Aug 08, 1983
EMIT CAD QUINIDINE ASSAY FOR USE W/
Syva Co.
Chemistry
40d
Cleared
Jun 30, 1983
QUINIDINE REAGENT TEST KIT
Beckman Instruments, Inc.
Chemistry
94d
Cleared
Jun 02, 1983
EMIT QST QUINIDINE ASSAY
Syva Co.
Toxicology
37d
Cleared
Sep 28, 1982
TDX QUINIDINE
Abbott Laboratories
Toxicology
26d
Cleared
Sep 17, 1982
ADVANCE EMIT-CAD QUINIDINE ASSAY
Syva Co.
Toxicology
22d
Cleared
Jun 09, 1981
EMIT-CAD QUINIDINE ASSAY
Syva Co.
Toxicology
14d