FDA 510(k) Application Details - K083260

Device Classification Name	Myoglobin, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K083260
Device Name	Myoglobin, Antigen, Antiserum, Control
Applicant	Roche Diagnostics 9115 HAGUE ROAD P.O. BOX 50457 INDIANAPOLIS, IN 46250 US Other 510(k) Applications for this Company
Contact	JACK ROGERS 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	11/05/2008
Decision Date	10/16/2009
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