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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colorimetry, Cholinesterase
510(k) Number K863111
Device Name CHOLINESTERASE
Applicant
J. D. Assoc.
163 Montclair Ave.
Montclair,  NJ  07042
Applicant Contact DI PIETRO
Correspondent
J. D. Assoc.
163 Montclair Ave.
Montclair,  NJ  07042
Correspondent Contact DI PIETRO
Regulation Number862.3240
Classification Product Code
DIH  
Date Received08/13/1986
Decision Date 09/11/1986
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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