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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 -4737
Applicant Contact Bill Hyatt
Correspondent
Mrl Diagnostics
10703 Progress Way
Cypress,  CA  90630 -4737
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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