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

27 devices

25–27 of 27

Cleared Sep 17, 1982

ADVANCE EMIT-CAD QUINIDINE ASSAY

Toxicology · 22d

Cleared Oct 19, 1981

AMES TDA QUINIDINE TEST

Miles Laboratories, Inc.

Toxicology · 20d

Cleared Jun 09, 1981

EMIT-CAD QUINIDINE ASSAY

Toxicology · 14d