FDA 510(k) Application Details - K061181

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

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510(K) Number K061181
Device Name System, Test, Blood Glucose, Over The Counter
Applicant TaiDoc Technology Corporation
4F, 88, SEC.1, KWANG FU ROAD
SAN CHUNG, TAIPEI 241 TW
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Contact PI-SHIOU LI
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Regulation Number 862.1345

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Classification Product Code NBW
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Date Received 04/27/2006
Decision Date 07/06/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee CH - Clinical Chemistry
Review Advisory Committee CH - Clinical Chemistry
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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