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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, Barbiturate
510(k) Number K873623
Device Name ACA URINE BARBITURATES 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 Number862.3150
Classification Product Code
DIS  
Date Received09/08/1987
Decision Date 10/20/1987
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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