FDA 510(k) Application Details - K981012

Device Classification Name	Myoglobin, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K981012
Device Name	Myoglobin, Antigen, Antiserum, Control
Applicant	TOSOH MEDICS, INC. 373 VINTAGE PARK DR. SUITE D FOSTER CITY, CA 94404 US Other 510(k) Applications for this Company
Contact	LORI ROBINSON 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	03/18/1998
Decision Date	05/28/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review