FDA 510(k) Application Details - K970396

Device Classification Name	Calibrator, Surrogate   More FDA Info for this Device
510(K) Number	K970396
Device Name	Calibrator, Surrogate
Applicant	DADE CHEMISTRY SYSTEMS, INC. RT. 896, GLASCOW BLDG. 500 GLASGOW, DE 19702 US Other 510(k) Applications for this Company
Contact	REBECCA S AYASH Other 510(k) Applications for this Contact
Regulation Number	862.1150   More FDA Info for this Regulation Number
Classification Product Code	JIW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/03/1997
Decision Date	02/20/1997
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