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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 K955498
Device Name CHOLINESTERASE ASSAY KIT, CATALOGUE# 300-05
Applicant
Diagnostic Chemicals , Ltd.
West Royalty Industrial Park,
Charlottetown, P.E.I.,  CA C1E 2A6
Applicant Contact KAREN CALLBECK
Correspondent
Diagnostic Chemicals , Ltd.
West Royalty Industrial Park,
Charlottetown, P.E.I.,  CA C1E 2A6
Correspondent Contact KAREN CALLBECK
Regulation Number862.3240
Classification Product Code
DIH  
Date Received12/01/1995
Decision Date 01/24/1996
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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