FDA 510(k) Application Details - K981474

Device Classification Name	Multi-Analyte Controls, All Kinds (Assayed)   More FDA Info for this Device
510(K) Number	K981474
Device Name	Multi-Analyte Controls, All Kinds (Assayed)
Applicant	SPECTRAL DIAGNOSTICS, INC. 135-2 THE WEST MALL TORONTO, ONTARIO M9C1C2 CA Other 510(k) Applications for this Company
Contact	JOSEPH LAURINO Other 510(k) Applications for this Contact
Regulation Number	862.1660   More FDA Info for this Regulation Number
Classification Product Code	JJY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/24/1998
Decision Date	05/07/1998
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