LBZ · Class II · 21 CFR 862.3320

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
1–24 of 27
Cleared Jan 12, 2004
ROCHE ONLINE TDM QUINIDINE
K032332
Roche Diagnostics Corp.
Toxicology · 167d
Cleared Jul 06, 1994
COBAS-FP QUINIDINE REAGENTS AND CALIBRATORS
K941440
Roche Diagnostic Systems, Inc.
Toxicology · 104d
Cleared Aug 24, 1992
EMIT 2000 QUINDINE ASSAY QUIDIDINE CALIBRATORS
K922913
Syva Co.
Chemistry · 68d
Cleared Feb 04, 1991
EMIT CONVENIENCE PACK, QUINIDINE ASSAY/CALIBRATORS
K904990
Syva Co.
Toxicology · 90d
Cleared Aug 13, 1987
TDXR FLECAINIDE
K872175
Abbott Laboratories
Chemistry · 66d
Cleared Jan 08, 1987
EASY-TEST QUINIDINE ITEM NO. 67---/95
K864607
Em Diagnostic Systems, Inc.
Toxicology · 45d
Cleared Jun 27, 1986
EMIT QUINIDINE ASSAY
K862214
Syva Co.
Toxicology · 17d
Cleared Mar 25, 1985
COBAS FP REAGENTS FOR QUINIDINE
K850808
Roche Diagnostic Systems, Inc.
Toxicology · 26d
Cleared Aug 29, 1984
TDX DISOPYRAMIDE
K842713
Abbott Laboratories
Chemistry · 48d
Cleared Apr 04, 1984
QUINIDINE ANALYTICAL TEST PACK
K840596
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 55d
Cleared Aug 08, 1983
EMIT CAD QUINIDINE ASSAY FOR USE W/
K832096
Syva Co.
Chemistry · 40d
Cleared Jun 30, 1983
QUINIDINE REAGENT TEST KIT
K830963
Beckman Instruments, Inc.
Chemistry · 94d
Cleared Jun 02, 1983
EMIT QST QUINIDINE ASSAY
K831355
Syva Co.
Toxicology · 37d
Cleared Sep 28, 1982
TDX QUINIDINE
K822653
Abbott Laboratories
Toxicology · 26d
Cleared Sep 17, 1982
ADVANCE EMIT-CAD QUINIDINE ASSAY
K822588
Syva Co.
Toxicology · 22d
Cleared Jun 09, 1981
EMIT-CAD QUINIDINE ASSAY
K811460
Syva Co.
Toxicology · 14d

About Product Code LBZ - Regulatory Context