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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antisera, Fluorescent, Herpesvirus Hominis 1,2
510(k) Number K771063
Device Name HSV TEST
Applicant
Gull Laboratories, Inc.
UT 
Correspondent
Gull Laboratories, Inc.
UT 
Regulation Number866.3305
Classification Product Code
GQL  
Date Received06/13/1977
Decision Date 07/11/1977
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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