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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antibody Igm, If, Epstein-Barr Virus
510(k) Number K073381
Device Name PLEXUS EBV IGM MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0600M
Applicant
Focus Diagnostics, Inc.
10703 Progress Way
Cypress,  CA  90630
Applicant Contact CONSTANCE BRIDGES
Correspondent
Focus Diagnostics, Inc.
10703 Progress Way
Cypress,  CA  90630
Correspondent Contact CONSTANCE BRIDGES
Regulation Number866.3235
Classification Product Code
LJN  
Date Received12/03/2007
Decision Date 08/04/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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