FDA 510(k) Application Details - K051727

Device Classification Name	Dye-Indicator, Ph (Urinary, Non-Quant.)   More FDA Info for this Device
510(K) Number	K051727
Device Name	Dye-Indicator, Ph (Urinary, Non-Quant.)
Applicant	GERMAINE LABORATORIES, INC. 4139 GARDENDALE CENTER, SUITE 101 SAN ANTONIO, TX 78229 US Other 510(k) Applications for this Company
Contact	MARTIN O'CONNOR 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	06/28/2005
Decision Date	10/26/2005
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