FDA 510(k) Application Details - K083628

Device Classification Name	System, Test, Blood Glucose, Over The Counter   More FDA Info for this Device
510(K) Number	K083628
Device Name	System, Test, Blood Glucose, Over The Counter
Applicant	ALL MEDICUS CO., LTD 7068 DONG-IL TECHNO TOWN 7TH 823 GWANYANG 2-DONG ANYANG, GYEONGGI-DO 431-062 KR Other 510(k) Applications for this Company
Contact	MARGARET KIM Other 510(k) Applications for this Contact
Regulation Number	862.1345   More FDA Info for this Regulation Number
Classification Product Code	NBW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/08/2008
Decision Date	05/01/2009
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