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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 K842662
Device Name ANTI-EPSTEIN-BARR VIRUS KIT
Applicant
Amico Lab, Inc.
TN  37209 -
Correspondent
Amico Lab, Inc.
TN  37209 -
Regulation Number866.3235
Classification Product Code
GNP  
Date Received07/10/1984
Decision Date 12/12/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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