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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Multi-Analyte Mixture
510(k) Number K935543
Device Name ACA PLUS FERRITIN CALIBRATOR
Applicant
E.I. Dupont DE Nemours & Co., Inc.
Wilmington,  DE  19898
Applicant Contact REBECCA S AYASH
Correspondent
E.I. Dupont DE Nemours & Co., Inc.
Wilmington,  DE  19898
Correspondent Contact REBECCA S AYASH
Regulation Number862.1150
Classification Product Code
JIX  
Date Received11/16/1993
Decision Date 03/22/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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