FDA 510(k) Application Details - K051564

Device Classification Name	Cardiac C-Reactive Protein, Antigen, Antiserum, And Control   More FDA Info for this Device
510(K) Number	K051564
Device Name	Cardiac C-Reactive Protein, Antigen, Antiserum, And Control
Applicant	OLYMPUS AMERICA, INC. 3131 WEST ROYAL LN. IRVING, TX 75063-3104 US Other 510(k) Applications for this Company
Contact	BEV HARDING Other 510(k) Applications for this Contact
Regulation Number	866.5270   More FDA Info for this Regulation Number
Classification Product Code	NQD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/14/2005
Decision Date	08/22/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review