FDA 510(k) Application Details - K080014

Device Classification Name System, Test, Blood Glucose, Over The Counter

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510(K) Number K080014
Device Name System, Test, Blood Glucose, Over The Counter
Applicant TaiDoc Technology Corporation
6F, NO. 127, WUGONG 2ND RD
WUGU TOWNSHIP
TAIPEI COUNTY 241 TW
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Contact Yuhua Chen
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Regulation Number 862.1345

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Classification Product Code NBW
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Date Received 01/03/2008
Decision Date 06/09/2008
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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