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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 K915084
Device Name BECKMAN SYCHRON(TM) TRIGLYCERIDES REAGENT
Applicant
BECKMAN INSTRUMENTS, INC.
200 SOUTH KRAEMER BLVD., W-337
BOX 8000
BREA,  CA  92622 -8000
Applicant Contact WILLIAM T RYAN
Correspondent
BECKMAN INSTRUMENTS, INC.
200 SOUTH KRAEMER BLVD., W-337
BOX 8000
BREA,  CA  92622 -8000
Correspondent Contact WILLIAM T RYAN
Regulation Number862.1705
Classification Product Code
CDT  
Date Received11/12/1991
Decision Date 01/28/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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