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FDA 510(k) Application Details - K101509
Device Classification Name
System, Test, Blood Glucose, Over The Counter
More FDA Info for this Device
510(K) Number
K101509
Device Name
System, Test, Blood Glucose, Over The Counter
Applicant
TaiDoc Technology Corporation
3F,5F, NO.127 WUGONG 2ND RD,
WUGU TOWNSHIP
TAIPEI COUNTY 24888 TW
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Contact
TELING HSU
Other 510(k) Applications for this Contact
Regulation Number
862.1345
More FDA Info for this Regulation Number
Classification Product Code
NBW
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More FDA Info for this Product Code
Date Received
06/01/2010
Decision Date
06/27/2011
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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