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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antisera, Cf, Herpesvirus Hominis 1,2
510(k) Number K861120
Device Name THE GOLDEN QUAD TEST (HSV)
Applicant
Microbiological Research Corp.
P.O. Box 308
Bountiful,  UT  84010
Applicant Contact CAROLE A GOLDEN
Correspondent
Microbiological Research Corp.
P.O. Box 308
Bountiful,  UT  84010
Correspondent Contact CAROLE A GOLDEN
Regulation Number866.3305
Classification Product Code
GQO  
Date Received03/25/1986
Decision Date 02/02/1987
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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