FDA 510(k) Application Details - K091287

Device Classification Name	Dye-Indicator, Ph (Urinary, Non-Quant.)   More FDA Info for this Device
510(K) Number	K091287
Device Name	Dye-Indicator, Ph (Urinary, Non-Quant.)
Applicant	COMMON SENSE, LTD. 777 6TH STREET NW SUITE 1100 WASHINGTON, DC 20001 US Other 510(k) Applications for this Company
Contact	NATASHA LESKOVSEK Other 510(k) Applications for this Contact
Regulation Number	862.1550   More FDA Info for this Regulation Number
Classification Product Code	CEN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/01/2009
Decision Date	08/31/2009
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