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FDA 510(k) Application Details - K103531
Device Classification Name
Hexokinase, Glucose
More FDA Info for this Device
510(K) Number
K103531
Device Name
Hexokinase, Glucose
Applicant
TOKYO BOEKI MEDISYS INC.
5105 FAIROAKS ROAD
DURHAM, NC 27712 US
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Contact
James M Clinton
Other 510(k) Applications for this Contact
Regulation Number
862.1345
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Classification Product Code
CFR
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/01/2010
Decision Date
12/01/2011
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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