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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.
CA  92037 -
Correspondent
Behring Diagnostics, Inc.
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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