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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 K832875
Device Name CORDIA HS
Applicant
Cordis Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Cordis Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number866.3305
Classification Product Code
GQN  
Date Received08/26/1983
Decision Date 11/28/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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