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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 K914609
Device Name TRIGLYCERIDES REAGENT SET
Applicant
Sterling Diagnostics, Inc.
6226 Product Dr.
Sterling Heights,  MI  48312
Applicant Contact DAVID L CALLENDER
Correspondent
Sterling Diagnostics, Inc.
6226 Product Dr.
Sterling Heights,  MI  48312
Correspondent Contact DAVID L CALLENDER
Regulation Number862.1705
Classification Product Code
CDT  
Date Received10/17/1991
Decision Date 11/07/1991
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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