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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Beta-Globulin, Antigen, Antiserum, Control
510(k) Number K891093
Device Name ACA (R) DIGITOXIN CALIBRATOR
Applicant
E.I. Dupont DE Nemours & Co., Inc.
Medical Products Dept.
Barley Mill Plz., P22-1170
Wilmington,  DE  19898
Applicant Contact RICHARD M VAUGHT
Correspondent
E.I. Dupont DE Nemours & Co., Inc.
Medical Products Dept.
Barley Mill Plz., P22-1170
Wilmington,  DE  19898
Correspondent Contact RICHARD M VAUGHT
Regulation Number866.5160
Classification Product Code
DCJ  
Date Received03/02/1989
Decision Date 04/26/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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