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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 K103531
Device Name PRESTIGE 24I; BIOLIS 24I; MGC 240
Applicant
Tokyo Boeki Medisys, Inc.
5105 Fairoaks Rd.
Durham,  NC  27712
Applicant Contact James M Clinton
Correspondent
Tokyo Boeki Medisys, Inc.
5105 Fairoaks Rd.
Durham,  NC  27712
Correspondent Contact James M Clinton
Regulation Number862.1345
Classification Product Code
CFR  
Subsequent Product Code
JJE  
Date Received12/01/2010
Decision Date 12/01/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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