FDA 510(k) Application Details - K972408

Device Classification Name	Enzyme Controls (Assayed And Unassayed)   More FDA Info for this Device
510(K) Number	K972408
Device Name	Enzyme Controls (Assayed And Unassayed)
Applicant	SPECTRAL DIAGNOSTICS, INC. 135-2 THE WEST MALL TORONTO, ONTARIO M9C1C2 CA Other 510(k) Applications for this Company
Contact	FRANCEE S BOCHES Other 510(k) Applications for this Contact
Regulation Number	862.1660   More FDA Info for this Regulation Number
Classification Product Code	JJT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/26/1997
Decision Date	07/25/1997
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