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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 K904167
Device Name PATHODX HERPES TYPING
Applicant
Diagnostic Products Corp.
5700 W. 96th St.
Los Angeles,  CA  90045
Applicant Contact KENNETH B ASARCH
Correspondent
Diagnostic Products Corp.
5700 W. 96th St.
Los Angeles,  CA  90045
Correspondent Contact KENNETH B ASARCH
Regulation Number866.3305
Classification Product Code
GQL  
Date Received09/11/1990
Decision Date 12/13/1990
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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