FDA 510(k) Application Details - K081714

Device Classification Name Glucose Oxidase, Glucose

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510(K) Number K081714
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
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Regulation Number 862.1345

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Classification Product Code CGA
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Date Received 06/18/2008
Decision Date 07/25/2008
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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