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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Ion Specific, Potassium
510(k) Number K110520
Device Name BIOLIS 12I
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 Number862.1600
Classification Product Code
CEM  
Subsequent Product Codes
CFR   CGZ   JGS   JJE  
Date Received02/23/2011
Decision Date 03/23/2012
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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