FDA 510(k) Application Details - K031843

Device Classification Name	System, Test, Blood Glucose, Over The Counter   More FDA Info for this Device
510(K) Number	K031843
Device Name	System, Test, Blood Glucose, Over The Counter
Applicant	MEDLINE INDUSTRIES, INC. ONE MEDLINE PL. MUNDELEIN, IL 60060-4486 US Other 510(k) Applications for this Company
Contact	ANDREA HAFERKAMP 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	06/16/2003
Decision Date	07/03/2003
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review