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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 K854783
Device Name TRIGLYCERIDE'S TEST (TRIGLI-CINET)
Applicant
Sclavo, Inc.
5 Mansard Court
Wayne,  NJ  07470
Applicant Contact DEBRA HOFMEISTER
Correspondent
Sclavo, Inc.
5 Mansard Court
Wayne,  NJ  07470
Correspondent Contact DEBRA HOFMEISTER
Regulation Number862.1705
Classification Product Code
CDT  
Date Received11/29/1985
Decision Date 01/22/1986
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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