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FDA 510(k) Application Details - K110520
Device Classification Name
Electrode, Ion Specific, Potassium
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510(K) Number
K110520
Device Name
Electrode, Ion Specific, Potassium
Applicant
TOKYO BOEKI MEDISYS INC.
5105 FAIROAKS ROAD
DURHAM, NC 27712 US
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Contact
James M Clinton
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Regulation Number
862.1600
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Classification Product Code
CEM
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More FDA Info for this Product Code
Date Received
02/23/2011
Decision Date
03/23/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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