FDA 510(k) Application Details - K022409

Device Classification Name	Chromatographic Separation, Cpk Isoenzymes   More FDA Info for this Device
510(K) Number	K022409
Device Name	Chromatographic Separation, Cpk Isoenzymes
Applicant	SPECTRAL DIAGNOSTICS, INC. 135-2 THE WEST MALL TORONTO, ONTARIO M9C1C2 CA Other 510(k) Applications for this Company
Contact	NISAR A SHAIKH Other 510(k) Applications for this Contact
Regulation Number	862.1215   More FDA Info for this Regulation Number
Classification Product Code	JHT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/24/2002
Decision Date	09/30/2002
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