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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 K883281
Device Name VIRGO HSV-2 IGG ELISA
Applicant
Electro-Nucleonics, Inc.
7101 Riverwood Dr.
Columbia,  MD  21046 -1297
Applicant Contact KAREN DARCY
Correspondent
Electro-Nucleonics, Inc.
7101 Riverwood Dr.
Columbia,  MD  21046 -1297
Correspondent Contact KAREN DARCY
Regulation Number866.3305
Classification Product Code
GQO  
Date Received08/03/1988
Decision Date 03/10/1989
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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