FDA 510(k) Application Details - K061742

Device Classification Name	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)   More FDA Info for this Device
510(K) Number	K061742
Device Name	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
Applicant	MACHEREY-NAGEL GMBH & CO., KG. 7361 CALHOUN PLACE, SUITE 500 ROCKVILLE, MD 20855 US Other 510(k) Applications for this Company
Contact	ARMOND WELCH Other 510(k) Applications for this Contact
Regulation Number	862.1340   More FDA Info for this Regulation Number
Classification Product Code	JIL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/20/2006
Decision Date	09/06/2006
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