FDA 510(k) Application Details - K954326

Device Classification Name	Calibrator, Secondary   More FDA Info for this Device
510(K) Number	K954326
Device Name	Calibrator, Secondary
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	862.1150   More FDA Info for this Regulation Number
Classification Product Code	JIT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/15/1995
Decision Date	07/23/1996
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