FDA 510(k) Application Details - K141925

Device Classification Name	Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)   More FDA Info for this Device
510(K) Number	K141925
Device Name	Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)
Applicant	Roche Diagnostics Operations (RDO) 9115 Hague Road Indianapolis, IN 46250 US Other 510(k) Applications for this Company
Contact	PATRICK STIMART 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	07/16/2014
Decision Date	12/09/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review