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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
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