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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Antigen, Nuclear, Epstein-Barr Virus
510(k) Number K946353
Device Name EPSTEIN-BARR VIRUS NUCLEAR ANTIGEN RECOMBINANT IMMUNOFLUORESCENT ASSAY
Applicant
Mrl Diagnostics
10703 Progress Way
Cypress,  CA  90630
Applicant Contact Bill Hyatt
Correspondent
Mrl Diagnostics
10703 Progress Way
Cypress,  CA  90630
Correspondent Contact Bill Hyatt
Regulation Number866.3235
Classification Product Code
LLM  
Date Received12/30/1994
Decision Date 07/21/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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