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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, Echovirus 1-34
510(k) Number K853165
Device Name ECHO TYPE 30 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 Number866.3205
Classification Product Code
GNK  
Date Received07/30/1985
Decision Date 11/07/1985
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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