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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Acetylcholine Chloride, Specific Reagent For Pseudo Cholinesterase
510(k) Number K950180
Device Name DUPONT DIMENSION(R) PSEUDOCHOLINESTERASE METHOD
Applicant
E.I. Dupont DE Nemours & Co., Inc.
P.O. Box 80022
Barley Mill Plz., P22-1158
Wilmington,  DE  19880
Applicant Contact CATHY P CRAFT
Correspondent
E.I. Dupont DE Nemours & Co., Inc.
P.O. Box 80022
Barley Mill Plz., P22-1158
Wilmington,  DE  19880
Correspondent Contact CATHY P CRAFT
Regulation Number862.3240
Classification Product Code
DLI  
Subsequent Product Code
DIH  
Date Received01/17/1995
Decision Date 03/15/1995
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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