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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigen, Iha, Cytomegalovirus
510(k) Number K852494
Device Name CMV-IHA
Applicant
Hillcrest Biologicals
10703 Progress Way
Cypress,  CA  90630
Applicant Contact FULLER
Correspondent
Hillcrest Biologicals
10703 Progress Way
Cypress,  CA  90630
Correspondent Contact FULLER
Regulation Number866.3175
Classification Product Code
LJO  
Date Received06/12/1985
Decision Date 09/16/1985
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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