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FDA 510(k) Application Details - K113077
Device Classification Name
System, Test, Blood Glucose, Over The Counter
More FDA Info for this Device
510(K) Number
K113077
Device Name
System, Test, Blood Glucose, Over The Counter
Applicant
TaiDoc Technology Corporation
3F, 5F, NO 127 WUGONG 2ND RD
WUGU TOWNSHIP, WUGU DIST
NEW TAIPEI CITY 24888 TW
Other 510(k) Applications for this Company
Contact
LINDA KO
Other 510(k) Applications for this Contact
Regulation Number
862.1345
More FDA Info for this Regulation Number
Classification Product Code
NBW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/17/2011
Decision Date
08/03/2012
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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