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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 K933722
Device Name HORIZON DIAGNOSTICS TRIGLYCERIDES-GPO REAGENT
Applicant
HORIZON DIAGNOSTICS, INC.
3660 PLAZA DRIVE,STE.4
ANN ARBOR,  MI  48108
Applicant Contact DAVID CALLENDER
Correspondent
HORIZON DIAGNOSTICS, INC.
3660 PLAZA DRIVE,STE.4
ANN ARBOR,  MI  48108
Correspondent Contact DAVID CALLENDER
Regulation Number862.1705
Classification Product Code
CDT  
Date Received08/02/1993
Decision Date 06/13/1996
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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