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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hexokinase, Glucose
510(k) Number K031135
Device Name GLUCOSE FLEX REAGENT CARTRIDGE (GLUC)
Applicant
Dade Behring, Inc.
P.O. Box 6101
Glasgow Bldg. 500
Newark,  DE  19714 -6101
Applicant Contact LORRAINE PIESTRAK
Correspondent
Dade Behring, Inc.
P.O. Box 6101
Glasgow Bldg. 500
Newark,  DE  19714 -6101
Correspondent Contact LORRAINE PIESTRAK
Regulation Number862.1345
Classification Product Code
CFR  
Date Received04/09/2003
Decision Date 06/02/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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