FDA 510(k) Application Details - K955905

Device Classification Name	Biuret (Colorimetric), Total Protein   More FDA Info for this Device
510(K) Number	K955905
Device Name	Biuret (Colorimetric), Total Protein
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	862.1635   More FDA Info for this Regulation Number
Classification Product Code	CEK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/29/1995
Decision Date	05/30/1996
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