FDA 510(k) Application Details - K954158

Device Classification Name	Automated Urinalysis System   More FDA Info for this Device
510(K) Number	K954158
Device Name	Automated Urinalysis System
Applicant	SOLARCARE TECHNOLOGIES CORP,INC. 1745 EATON AVE. BETHLEHEM, PA 18018-1799 US Other 510(k) Applications for this Company
Contact	R. SAM NIEDBALA Other 510(k) Applications for this Contact
Regulation Number	862.2900   More FDA Info for this Regulation Number
Classification Product Code	KQO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/05/1995
Decision Date	04/30/1996
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