FDA 510(k) Application Details - K141036

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

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510(K) Number K141036
Device Name System, Test, Blood Glucose, Over The Counter
Applicant APEX BIOTECHNOLOGY CORP.
NO. 7, LI-HSIN ROAD V,
HSINCHU SCIENCE PARK
HSINCHU 30078 TW
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Contact HSUE-MEI LEE
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Regulation Number 862.1345

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Classification Product Code NBW
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Date Received 04/22/2014
Decision Date 05/01/2015
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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