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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ferritin, Antigen, Antiserum, Control
510(k) Number K935528
Device Name DUPONT ACA(R) PLUS IMMUNOASSAY SYS FERRITIN(FERR) METH
Applicant
E.I. Dupont DE Nemours & Co., Inc.
P.O. Box 80022
Wilmington,  DE  19880
Applicant Contact REBECCA S AYASH
Correspondent
E.I. Dupont DE Nemours & Co., Inc.
P.O. Box 80022
Wilmington,  DE  19880
Correspondent Contact REBECCA S AYASH
Regulation Number866.5340
Classification Product Code
DBF  
Date Received11/16/1993
Decision Date 01/28/1994
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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