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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
510(k) Number K903897
Device Name TRIGLYCERIDES REAGENT GPO 5 X CONC.
Applicant
Trace Scientific , Ltd.
P.O. Box 310
Clayton, Australia 3168,  AU 3168
Applicant Contact PETER MURPHY
Correspondent
Trace Scientific , Ltd.
P.O. Box 310
Clayton, Australia 3168,  AU 3168
Correspondent Contact PETER MURPHY
Regulation Number862.1705
Classification Product Code
CDT  
Date Received08/23/1990
Decision Date 10/01/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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