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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 K922964
Device Name KING DIAGNOSTIC TRIGLYCERIDES REAGENT
Applicant
King Diagnostics, Inc.
6856 Hawthorn Park Dr.
Indianapolis,  IN  46220
Applicant Contact FRANCES LOH
Correspondent
King Diagnostics, Inc.
6856 Hawthorn Park Dr.
Indianapolis,  IN  46220
Correspondent Contact FRANCES LOH
Regulation Number862.1705
Classification Product Code
CDT  
Date Received06/19/1992
Decision Date 08/18/1992
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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