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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Epstein-Barr Virus, Other
510(k) Number K872617
Device Name EBV-EA TEST
Applicant
Gull Laboratories, Inc.
1011 E. 4800 S.
Salt Lake City,  UT  84117
Applicant Contact RACHFORD, PHD
Correspondent
Gull Laboratories, Inc.
1011 E. 4800 S.
Salt Lake City,  UT  84117
Correspondent Contact RACHFORD, PHD
Regulation Number866.3235
Classification Product Code
LSE  
Date Received07/06/1987
Decision Date 01/05/1988
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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