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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 K843751
Device Name CORDIA HS ANTIBODY TYPING REAGENTS
Applicant
Cordis Corp.
P.O. Box 025700
Miami,  FL  33102
Applicant Contact SEYMOUR P HALBERT
Correspondent
Cordis Corp.
P.O. Box 025700
Miami,  FL  33102
Correspondent Contact SEYMOUR P HALBERT
Regulation Number866.3305
Classification Product Code
GQN  
Date Received09/25/1984
Decision Date 04/24/1985
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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