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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, opiates
510(k) Number K872391
Device Name ACA DU PONT URINE OPIATES (U OPI) SCREEN METHOD
Applicant
E.I. DUPONT DE NEMOURS & CO., INC.
MEDICAL PRODUCTS DEPARTMENT
BARLEY MILL PLAZA, P22-1170
wilmington,  DE  19898
Applicant Contact grace h singles
Correspondent
E.I. DUPONT DE NEMOURS & CO., INC.
MEDICAL PRODUCTS DEPARTMENT
BARLEY MILL PLAZA, P22-1170
wilmington,  DE  19898
Correspondent Contact grace h singles
Regulation Number862.3650
Classification Product Code
DJG  
Date Received06/19/1987
Decision Date 08/10/1987
Decision substantially equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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