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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 K771608
Device Name A-GENT TRIGLYCERIDES
Applicant
ABBOTT LABORATORIES
ONE ABBOTT PARK RD.
ABBOTT PARK,  IL  60064 -3500
Correspondent
ABBOTT LABORATORIES
ONE ABBOTT PARK RD.
ABBOTT PARK,  IL  60064 -3500
Regulation Number862.1705
Classification Product Code
CDT  
Date Received08/22/1977
Decision Date 09/15/1977
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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