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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 K841245
Device Name ENZYGNOST ANTIHERPES SIMPLEX VIRUS
Applicant
Behring Diagnostics, Inc.
La Jolla,  CA  92037
Correspondent
Behring Diagnostics, Inc.
La Jolla,  CA  92037
Regulation Number866.3305
Classification Product Code
GQO  
Date Received03/23/1984
Decision Date 11/05/1985
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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