FDA 510(k) Application Details - K043311

Device Classification Name	System, Test, Blood Glucose, Over The Counter   More FDA Info for this Device
510(K) Number	K043311
Device Name	System, Test, Blood Glucose, Over The Counter
Applicant	BAYER HEALTHCARE, LLC 1884 MILES AVE. P.O. BOX 70 ELKHART, IN 46514-0070 US Other 510(k) Applications for this Company
Contact	GEORGE M TANCOS 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	12/01/2004
Decision Date	12/22/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review