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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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