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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 K860690
Device Name TRIGLYCERIDES FOR CONTINUOUS FLOW INSTRUMENTS
Applicant
CATACHEM, INC.
6 NORTH PEARL ST.
PORT CHESTER,  NY  10573
Applicant Contact LUIS P LEON
Correspondent
CATACHEM, INC.
6 NORTH PEARL ST.
PORT CHESTER,  NY  10573
Correspondent Contact LUIS P LEON
Regulation Number862.1705
Classification Product Code
CDT  
Date Received02/25/1986
Decision Date 03/17/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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