FDA 510(k) Application Details - K963142

Device Classification Name	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)   More FDA Info for this Device
510(K) Number	K963142
Device Name	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
Applicant	BAYER CORP. 1884 MILES AVE. P.O. BOX 70 ELKHART, IN 46514-0070 US Other 510(k) Applications for this Company
Contact	ROSANNE M SAVOL, R.A.C. 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	08/13/1996
Decision Date	09/27/1996
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