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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 K883670
Device Name SEROLOGICAL TEST KIT FOR IGG ANTI. EPSTEIN-BARR VI
Applicant
Electro-Nucleonics, Inc.
8310 Guilford Rd.
Columbia,  MD  21046
Applicant Contact KAREN DARCY
Correspondent
Electro-Nucleonics, Inc.
8310 Guilford Rd.
Columbia,  MD  21046
Correspondent Contact KAREN DARCY
Regulation Number866.3235
Classification Product Code
GNP  
Date Received08/18/1988
Decision Date 04/28/1989
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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