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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colorimetry, Salicylate
510(k) Number K042329
Device Name SALICYLATE-SL ASSAY
Applicant
Diagnostic Chemicals , Ltd.
16 Mccarville St.
West Royalty Industrial Park
Charlottetown, Prince Edward,  CA C1E 2A6
Applicant Contact NANCY OLSCAMP
Correspondent
Diagnostic Chemicals , Ltd.
16 Mccarville St.
West Royalty Industrial Park
Charlottetown, Prince Edward,  CA C1E 2A6
Correspondent Contact NANCY OLSCAMP
Regulation Number862.3830
Classification Product Code
DKJ  
Date Received08/27/2004
Decision Date 12/27/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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