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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 K861121
Device Name THE GOLDEN QUAD TEST (EBV)
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 Number866.3235
Classification Product Code
GNP  
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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