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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 K903016
Device Name SYNERMED TRIGLYCERIDES REAGENT KIT
Applicant
Synermed, Inc.
445 Boul. Industriel
St-Eustanche
Quebec,  CA J745R3
Applicant Contact MARCIA ARENTZ
Correspondent
Synermed, Inc.
445 Boul. Industriel
St-Eustanche
Quebec,  CA J745R3
Correspondent Contact MARCIA ARENTZ
Regulation Number862.1705
Classification Product Code
CDT  
Date Received07/10/1990
Decision Date 07/27/1990
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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