FDA 510(k) Application Details - K042924

Device Classification Name	Myoglobin, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K042924
Device Name	Myoglobin, Antigen, Antiserum, Control
Applicant	FISHER DIAGNOSTICS 8365 VALLEY PIKE, PO BX 307 MIDDLETOWN, VA 22645 US Other 510(k) Applications for this Company
Contact	JOSEFINA INFANTAS 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	10/22/2004
Decision Date	01/24/2005
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