FDA 510(k) Application Details - K050985

Device Classification Name	System, Test, Blood Glucose, Over The Counter   More FDA Info for this Device
510(K) Number	K050985
Device Name	System, Test, Blood Glucose, Over The Counter
Applicant	ALL MEDICUS CO., LTD 7106 DONG-IL TECHO TOWN 7TH 823 KWANYANG DONG DONGAN-GU ANYANG, GYEONGGI-DO 431-062 KR Other 510(k) Applications for this Company
Contact	JE YOUNG CHANG 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	04/19/2005
Decision Date	10/07/2005
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