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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Immunoassay, Digoxin
510(k) Number K932732
Device Name ACA(R) DIGOXIN ANALYTICAL TEST PACK (DGN)
Applicant
Dupont Medical Products
P.O. Box 80022, Bmp 22-1174
Wilmington,  DE  19880 -0022
Applicant Contact REBECCA S AYASH
Correspondent
Dupont Medical Products
P.O. Box 80022, Bmp 22-1174
Wilmington,  DE  19880 -0022
Correspondent Contact REBECCA S AYASH
Regulation Number862.3320
Classification Product Code
KXT  
Date Received06/07/1993
Decision Date 11/15/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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