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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 K843832
Device Name TRIGLYCERIDES REAGENT SYSTEM
Applicant
Fermco Biochemics, Inc.
2020 Lunt Ave.
Elk Grove Village,  IL  60007
Applicant Contact FRANK E HAMMER
Correspondent
Fermco Biochemics, Inc.
2020 Lunt Ave.
Elk Grove Village,  IL  60007
Correspondent Contact FRANK E HAMMER
Regulation Number862.1705
Classification Product Code
CDT  
Date Received10/01/1984
Decision Date 11/27/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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