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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 K844032
Device Name TRIGLYCERIDE REAGENT
Applicant
SIGMA DIAGNOSTICS, INC.
P.O. BOX 14508
ST. LOUIS,  MO  63178
Applicant Contact MATHEW MADAPPALLY
Correspondent
SIGMA DIAGNOSTICS, INC.
P.O. BOX 14508
ST. LOUIS,  MO  63178
Correspondent Contact MATHEW MADAPPALLY
Regulation Number862.1705
Classification Product Code
CDT  
Date Received10/15/1984
Decision Date 11/09/1984
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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