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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
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