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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigens, Cf (Including Cf Control), Echovirus 1-34
510(k) Number K844967
Device Name ECHO TYPE 9 CF ANTIGEN
Applicant
Hillcrest Biologicals
3780 Woodruff Ave.
Long Beach,  CA  90808
Applicant Contact LOUIS D CULLMAN
Correspondent
Hillcrest Biologicals
3780 Woodruff Ave.
Long Beach,  CA  90808
Correspondent Contact LOUIS D CULLMAN
Regulation Number866.3205
Classification Product Code
GNL  
Date Received12/24/1984
Decision Date 03/05/1985
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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