LJM · Class II · 21 CFR 866.5100

FDA Product Code LJM: Antinuclear Antibody (enzyme-labeled), Antigen, Controls

Leading manufacturers include Elias U.S.A., Inc., American Laboratory Products Co., Ltd. and Zeus Scientific, Inc..

112
Total
112
Cleared
99d
Avg days
1982
Since
112 devices
73–96 of 112
Cleared Jan 24, 1990
IMMUNODOT AUTOIMMUNITY SCREENING PANEL 2
K900072
General Biometrics, Inc.
Immunology · 19d
Cleared Dec 05, 1989
IMMUNODOT AUTOIMMUNE SCREENING PANEL 1
K896347
General Biometrics, Inc.
Immunology · 32d
Cleared Aug 24, 1989
ANTI-SM MICROASSAY
K894894
Diamedix Corp.
Immunology · 23d
Cleared Nov 01, 1984
DNA STAT TEST KIT
K843904
Whittaker Bioproducts, Inc.
Immunology · 29d
Cleared Sep 20, 1984
AMIZYME-ANA TEST KIT
K842532
Amico Lab, Inc.
Immunology · 84d
Cleared Sep 20, 1984
AMIZYME-ANDNA TEST KIT
K842533
Amico Lab, Inc.
Immunology · 84d
Cleared Nov 21, 1983
ENZYME ANA TEST SYSTEM
K833148
Immuno Concepts, Inc.
Immunology · 67d
Cleared Oct 08, 1982
HISTIMUNE ENZYME-ANA TEST
K822346
Icl Scientific
Immunology · 63d