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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 K981123
Device Name UREA
Applicant
Trace Scientific , Ltd.
189-199 Browns Rd.
Noble Park
Victoria,  AU 3174
Correspondent
Trace Scientific , Ltd.
189-199 Browns Rd.
Noble Park
Victoria,  AU 3174
Regulation Number862.1770
Classification Product Code
CDQ  
Date Received03/27/1998
Decision Date 04/24/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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