FDA 510(k) Applications for Medical Device Product Code "LJN"
(Antibody Igm, If, Epstein-Barr Virus)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K123021 | Bio-Rad Laboratories | BIOPLEX 2200 EBV IGM KIT | 11/02/2012 |
| K991459 | DIASORIN, INC. | COPALIS EBV-M ANTIBODY ASSAY | 05/14/1999 |
| K073381 | FOCUS DIAGNOSTICS, INC. | PLEXUS EBV IGM MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0600M | 08/04/2008 |
| K973939 | GenBio | IMMUNOWELL VCA IGM TEST | 08/10/1998 |
| K033780 | QUEST INTL., INC. | MODIFICATION TO SERAQUEST VCA IGM | 01/15/2004 |
| K990977 | QUEST INTL., INC. | SERAQUEST EB VAC IGM | 10/06/1999 |
| K042092 | ZEUS SCIENTIFIC, INC. | ATHENA MULTI-LYTE EBV VCA IGM TEST SYSTEM | 04/12/2005 |
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