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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 K010871
Device Name TGL FLEX REAGENT CARTRIDGE
Applicant
DADE BEHRING, INC.
514 GBC DR.
NEWARK,  DE  19702
Applicant Contact DONNA A WOLF
Correspondent
DADE BEHRING, INC.
514 GBC DR.
NEWARK,  DE  19702
Correspondent Contact DONNA A WOLF
Regulation Number862.1705
Classification Product Code
CDT  
Date Received03/23/2001
Decision Date 07/09/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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