FDA.reportPublic FDA data

510(k) K073381

Device
PLEXUS EBV IGM MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0600M
Applicant
Focus Diagnostics, Inc.
510(k) number
K073381
Product code
LJN
Decision
Substantially Equivalent (SESE)
Decision date
2008-08-04
Date received
2007-12-03
Regulation
866.3235
Classification name
Antibody Igm, If, Epstein-Barr Virus
Medical specialty
Microbiology
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
CONSTANCE BRIDGES
Address
10703 Progress Way Cypress CA US 90630 90630

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LJN#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K123021BIOPLEX 2200 EBV IGM KITBio-Rad Laboratories2012-11-02
K042092ATHENA MULTI-LYTE EBV VCA IGM TEST SYSTEMZeus Scientific, Inc.2005-04-12
K033780MODIFICATION TO SERAQUEST VCA IGMQuest Intl., Inc.2004-01-15
K990977SERAQUEST EB VAC IGMQuest Intl., Inc.1999-10-06
K991459COPALIS EBV-M ANTIBODY ASSAYDiaSorin, Inc.1999-05-14
K973939IMMUNOWELL VCA IGM TESTGenbio1998-08-10
K931520EPSTEIN-BARR VIRUS VCA (IGM) RECOMB IMMUN ANTIBODYMrl Diagnostics1994-04-26
K930020ORTHO*EPSTEIN-BARR VIRUS VCA-IGM ANTIBODY ELISAOrtho Diagnostic Systems, Inc.1993-07-16
K922331BARTELS EPSTEIN-BARR VIRUS IGM EIABaxter Diagnostics, Inc.1992-09-02
K915348EBV-VCA IGM ELISAPharmacia Diagnostics, Inc.1992-02-14
K911362AMIZYME EPSTEIN-BARR VIRUS (EBV) IGM ANTIBODY TESTAmico Laboratories, Inc.1991-10-07
K910042EBV IGM ELISA TESTGull Laboratories, Inc.1991-02-21
K901840(EIA) FOR IGM ANTIBODY TO EBV VCA IN HUMAN SERUMGranbio, Inc.1990-09-12
K896594EBV VCA ANTIBODY (IGM)Hillcrest Biologicals1990-01-16
K893240BION EBV-M (VCA) TEST SYSTEMBion Ent., Ltd.1989-07-14