FDA 510(k) Application Details - K982679

Device Classification Name	Myoglobin, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K982679
Device Name	Myoglobin, Antigen, Antiserum, Control
Applicant	SPECTRAL DIAGNOSTICS, INC. 135-2 THE WEST MALL TORONTO, ONTARIO M9C1C2 CA Other 510(k) Applications for this Company
Contact	JOSEPH LAURINE Other 510(k) Applications for this Contact
Regulation Number	866.5680   More FDA Info for this Regulation Number
Classification Product Code	DDR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/31/1998
Decision Date	10/07/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review