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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 K760011
Device Name REAGENT, TRIGLYCERIDES
Applicant
THE DOW CHEMICAL CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
THE DOW CHEMICAL CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.1705
Classification Product Code
CDT  
Date Received06/10/1976
Decision Date 07/26/1976
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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