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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antisera, Fluorescent, Herpesvirus Hominis 1,2
510(k) Number K904095
Device Name HERPES SIMPLEX VIRUS TISSUE CULTURE CONF. TYPING
Applicant
California Integrated Diagnostics, Inc.
433 Industrial Way
Benica,  CA  94510
Applicant Contact SUSAN C FULLER
Correspondent
California Integrated Diagnostics, Inc.
433 Industrial Way
Benica,  CA  94510
Correspondent Contact SUSAN C FULLER
Regulation Number866.3305
Classification Product Code
GQL  
Date Received09/06/1990
Decision Date 02/01/1991
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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