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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Urease And Glutamic Dehydrogenase, Urea Nitrogen
510(k) Number K002694
Device Name UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/30
Applicant
Diagnostic Chemicals , Ltd.
16 Mccarville St.
Charlottetown, P.E.,  CA C1E 2A6
Applicant Contact KAREN CALLBECK
Correspondent
Diagnostic Chemicals , Ltd.
16 Mccarville St.
Charlottetown, P.E.,  CA C1E 2A6
Correspondent Contact KAREN CALLBECK
Regulation Number862.1770
Classification Product Code
CDQ  
Date Received08/29/2000
Decision Date 09/15/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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