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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 K931520
Device Name EPSTEIN-BARR VIRUS VCA (IGM) RECOMB IMMUN ANTIBODY
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
LJN  
Date Received03/26/1993
Decision Date 04/26/1994
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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