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FDA 510(k) Application Details - K092902
Device Classification Name
System, Test, Blood Glucose, Over The Counter
More FDA Info for this Device
510(K) Number
K092902
Device Name
System, Test, Blood Glucose, Over The Counter
Applicant
TaiDoc Technology Corporation
6F, NO. 127, WUGONG 2ND RD
WUGU TOWNSHIP
TAIPEI COUNTY 24888 TW
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Contact
DEBRA LIANG
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
09/21/2009
Decision Date
03/02/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
TX - Clinical Toxicology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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