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FDA 510(k) Application Details - K081609
Device Classification Name
Glucose Oxidase, Glucose
More FDA Info for this Device
510(K) Number
K081609
Device Name
Glucose Oxidase, Glucose
Applicant
TaiDoc Technology Corporation
6F, NO. 127, WUGONG 2ND RD
WUGU TOWNSHIP
TAIPEI COUNTY 248 TW
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Contact
Yuhua Chen
Other 510(k) Applications for this Contact
Regulation Number
862.1345
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Classification Product Code
CGA
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More FDA Info for this Product Code
Date Received
06/09/2008
Decision Date
07/02/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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