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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 K871122
Device Name TRIGLYCERIDES DETERMINATION
Applicant
Biochemical Trade, Inc.
P.O. Box 520575
Miami,  FL  33152
Applicant Contact ALEJO V ROY
Correspondent
Biochemical Trade, Inc.
P.O. Box 520575
Miami,  FL  33152
Correspondent Contact ALEJO V ROY
Regulation Number862.1705
Classification Product Code
CDT  
Date Received03/20/1987
Decision Date 04/07/1987
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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