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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Complement C1q, Antigen, Antiserum, Control
510(k) Number K844294
Device Name CORDIA IC
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 Number866.5240
Classification Product Code
DAK  
Date Received11/06/1984
Decision Date 02/04/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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