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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 K895952
Device Name TRIGLYCERIDES TEST KIT
Applicant
ELITE TECHNOLOGY, INC.
#1 - 57 GALAXY BLVD.
TORONTO, ONTARIO
CANADA M9W 5P1,  CA
Applicant Contact CLIFFORD HATCHER
Correspondent
ELITE TECHNOLOGY, INC.
#1 - 57 GALAXY BLVD.
TORONTO, ONTARIO
CANADA M9W 5P1,  CA
Correspondent Contact CLIFFORD HATCHER
Regulation Number862.1705
Classification Product Code
CDT  
Date Received10/11/1989
Decision Date 01/11/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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