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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 K812471
Device Name SPIN-CHEM TRIGLYCERIDES REAGENT
Applicant
SMITH KLINE DIAGNOSTICS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
SMITH KLINE DIAGNOSTICS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.1705
Classification Product Code
CDT  
Date Received08/31/1981
Decision Date 09/14/1981
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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