FDA 510(k) Application Details - K013643

Device Classification Name	Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)   More FDA Info for this Device
510(K) Number	K013643
Device Name	Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)
Applicant	AUSAM BIOTECTHNOLOGIES INC 50 ROCKEFELLER PLAZA NEW YORK, NY 10020 US Other 510(k) Applications for this Company
Contact	LYNN ROLAND Other 510(k) Applications for this Contact
Regulation Number	862.1645   More FDA Info for this Regulation Number
Classification Product Code	JIQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/05/2001
Decision Date	08/14/2003
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