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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2
510(k) Number K850609
Device Name HERPES SIMPLEX GROUP CF ANTIGEN
Applicant
Hillcrest Biologicals
10703 Progress Way
Cypress,  CA  90630
Applicant Contact LOUIS C CULLMAN
Correspondent
Hillcrest Biologicals
10703 Progress Way
Cypress,  CA  90630
Correspondent Contact LOUIS C CULLMAN
Regulation Number866.3305
Classification Product Code
GQN  
Date Received02/15/1985
Decision Date 05/09/1985
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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