FDA 510(k) Application Details - K061419

Device Classification Name	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)   More FDA Info for this Device
510(K) Number	K061419
Device Name	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
Applicant	TECO DIAGNOSTICS 1268 NORTH LAKEVIEW AVE. ANAHEIM, CA 92807 US Other 510(k) Applications for this Company
Contact	JIAN VAECHES Other 510(k) Applications for this Contact
Regulation Number	862.1645   More FDA Info for this Regulation Number
Classification Product Code	JIR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/22/2006
Decision Date	01/26/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review