ClearanceBrief
Panels › Immunology › Product code LJM · Class 2

Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls

Regulation 866.5100

0510(k)s in 12 months (112 all time)
0recalls in 12 months (2 all time)
1recalls that name a 510(k)
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Top companies in LJM

Company510(k)sRecalls
Elias U.S.A., Inc.160
Zeus Scientific, Inc.61
American Laboratory Products Co., Ltd.60
Biohytech International, Inc.60
Theratest Laboratories, Inc.60
Lipogen, Inc.50
David A. Fuccillo, Ph.D.40
Orgentec40
Helix Diagnostics, Inc.30
Immco Diagnostics, Inc.30
Decided510(k)Device and applicantCode
Mar 17, 1987K870455SM EIA DIAGNOSTIC KIT
Biohytech International, Inc.
LJM
Mar 17, 1987K870452SS-DNA EIA DIAGNOSTIC KIT
Biohytech International, Inc.
LJM
Oct 24, 1986K862969ANA-ENZYME IMMUNOASSAY (ANA-EIA) DIAGNOSTIC KIT
Biohytech International, Inc.
LJM
Aug 1, 1985K852840ENZYME ANTINUCLEAR ANTIBODY SCREENING TEST
Modern Diagnostics, Inc.
LJM
Jul 10, 1985K852231ANA/LITE-HEP-2 TEST SYSTEM
Immuno-Products Industries
LJM
Jul 10, 1985K852230ANA/LITE-RL TEST SYSTEM
Immuno-Products Industries
LJM
Nov 1, 1984K843904DNA STAT TEST KIT
Whittaker Bioproducts, Inc.
LJM
Oct 25, 1984K843745ADP ANA APPLEZYME
Apple Diagnostic Products
LJM
Sep 20, 1984K842533AMIZYME-ANDNA TEST KIT
Amico Lab, Inc.
LJM
Sep 20, 1984K842532AMIZYME-ANA TEST KIT
Amico Lab, Inc.
LJM
Nov 21, 1983K833148ENZYME ANA TEST SYSTEM
Immuno Concepts, Inc.
LJM
Oct 8, 1982K822346HISTIMUNE ENZYME-ANA TEST
Icl Scientific
LJM

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