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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 K792480
Device Name CHEM-STRATE TRIGLYCERIDE
Applicant
General Diagnostics
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
General Diagnostics
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1705
Classification Product Code
CDT  
Date Received12/03/1979
Decision Date 12/27/1979
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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