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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antiserum, Cf, Epstein-Barr Virus
510(k) Number K771062
Device Name EBV TEST
Applicant
Gull Laboratories, Inc.
UT 
Correspondent
Gull Laboratories, Inc.
UT 
Regulation Number866.3235
Classification Product Code
GNP  
Date Received06/13/1977
Decision Date 07/14/1977
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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