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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 K871509
Device Name RESUBMITTED TRIGLYCERIDE GPO REAGENT (SINGLE VIAL)
Applicant
TRACE SCIENTIFIC LTD.
10 TREFOREST DR.
CLAYTON, VIC 3168,  AU
Applicant Contact WILLIAM C RIDDLE
Correspondent
TRACE SCIENTIFIC LTD.
10 TREFOREST DR.
CLAYTON, VIC 3168,  AU
Correspondent Contact WILLIAM C RIDDLE
Regulation Number862.1705
Classification Product Code
CDT  
Date Received04/16/1987
Decision Date 05/08/1987
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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