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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drug Specific Control Materials
510(k) Number K841533
Device Name ACA TRICYCLIC ANTIDEPRESSANTS SCREEN
Applicant
E.I. Dupont DE Nemours & Co., Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
E.I. Dupont DE Nemours & Co., Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number862.3280
Classification Product Code
LAS  
Date Received04/16/1984
Decision Date 05/11/1984
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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