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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bothrops Atrox Reagent
510(k) Number K852519
Device Name DUPONT ACA FIBRIN DEGRADATION PROD CLOTTING TUBE
Applicant
E.I. DUPONT DE NEMOURS & CO., INC.
MEDICAL PRODUCTS DEPARTMENT
BARLEY MILL PLAZA, P22-1170
WILMINGTON,  DE  19898
Applicant Contact ROGER C BRIDEN
Correspondent
E.I. DUPONT DE NEMOURS & CO., INC.
MEDICAL PRODUCTS DEPARTMENT
BARLEY MILL PLAZA, P22-1170
WILMINGTON,  DE  19898
Correspondent Contact ROGER C BRIDEN
Regulation Number864.8100
Classification Product Code
JCO  
Date Received06/17/1985
Decision Date 08/12/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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