LJN · Class I · 21 CFR 866.3235

FDA Product Code LJN: Antibody Igm, If, Epstein-barr Virus

Leading manufacturers include Immuno Concepts, Inc., Quest Intl., Inc. and Zeus Scientific, Inc..

24
Total
24
Cleared
160d
Avg days
1983
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times increasing: avg 249d recently vs 156d historically

FDA 510(k) Cleared Antibody Igm, If, Epstein-barr Virus Devices (Product Code LJN)

24 devices
1–24 of 24
Cleared Oct 02, 2026
Elecsys EBV IgM
K260233
Roche Diagnostics
Microbiology · 249d
Cleared Nov 02, 2012
BIOPLEX 2200 EBV IGM KIT
K123021
Bio-Rad Laboratories
Microbiology · 36d
Cleared Aug 04, 2008
PLEXUS EBV IGM MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0600M
K073381
Focus Diagnostics, Inc.
Microbiology · 245d
Cleared Apr 12, 2005
ATHENA MULTI-LYTE EBV VCA IGM TEST SYSTEM
K042092
Zeus Scientific, Inc.
Microbiology · 252d
Cleared Jan 15, 2004
MODIFICATION TO SERAQUEST VCA IGM
K033780
Quest Intl., Inc.
Microbiology · 42d
Cleared Oct 06, 1999
SERAQUEST EB VAC IGM
K990977
Quest Intl., Inc.
Microbiology · 197d
Cleared May 14, 1999
COPALIS EBV-M ANTIBODY ASSAY
K991459
DiaSorin, Inc.
Microbiology · 18d
Cleared Aug 10, 1998
IMMUNOWELL VCA IGM TEST
K973939
Genbio
Microbiology · 299d
Cleared Jul 16, 1993
ORTHO*EPSTEIN-BARR VIRUS VCA-IGM ANTIBODY ELISA
K930020
Ortho Diagnostic Systems, Inc.
Microbiology · 193d
Cleared Sep 02, 1992
BARTELS EPSTEIN-BARR VIRUS IGM EIA
K922331
Baxter Diagnostics, Inc.
Microbiology · 112d
Cleared Feb 21, 1991
EBV IGM ELISA TEST
K910042
Gull Laboratories, Inc.
Microbiology · 48d
Cleared Jan 16, 1990
EBV VCA ANTIBODY (IGM)
K896594
Hillcrest Biologicals
Microbiology · 56d
Cleared Jun 20, 1989
RESUBMITTED EBV/IGM-CHECK TEST KIT
K890639
Diagnostic Technology, Inc.
Microbiology · 132d
Cleared Aug 30, 1988
EBV-VCA IGM ANTIBODY TEST SYSTEM (ENZYME)
K880884
Immuno Concepts, Inc.
Microbiology · 181d
Cleared Aug 30, 1988
EBV-VCA IGM ANTIBODY TEST SYSTEM (FLUORESCENT)
K880886
Immuno Concepts, Inc.
Microbiology · 181d
Cleared Jul 08, 1988
DU PONT VCA-IGM ANTIBODY ELISA KIT
K875204
E.I. Dupont DE Nemours & Co., Inc.
Microbiology · 203d
Cleared May 13, 1988
ORTHO MONOLERT* RAPID ELISA TEST FOR INFECT. MONO.
K872541
Ortho Diagnostic Systems, Inc.
Microbiology · 319d
Cleared Dec 27, 1983
EBV-VCA-IGM IFA TEST SYSTEM
K833014
Zeus Scientific, Inc.
Immunology · 112d

About Product Code LJN - Regulatory Context

510(k) Submission Activity

24 total 510(k) submissions under product code LJN since 1983, with 24 receiving FDA clearance (average review time: 160 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - LJN Product Code

Recent submissions under LJN have taken an average of 249 days to reach a decision - up from 156 days historically. Manufacturers should account for longer review timelines in current project planning.

LJN devices are reviewed by the Microbiology panel. Browse all Microbiology devices →