FDA 510(k) Application Details - K082328

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

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510(K) Number K082328
Device Name System, Test, Blood Glucose, Over The Counter
Applicant ALL MEDICUS CO., LTD
823 GWANYANG 2-DONG
DONGAN-GU
ANYANG, GYEONGGI-DO 431-062 KR
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Contact MARGARET KIM
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Regulation Number 862.1345

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Classification Product Code NBW
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Date Received 08/14/2008
Decision Date 02/27/2009
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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