FDA 510(k) Application Details - K041863

Device Classification Name	System, Test, Rheumatoid Factor   More FDA Info for this Device
510(K) Number	K041863
Device Name	System, Test, Rheumatoid Factor
Applicant	Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. ROCHESTER, NY 14626-5101 US Other 510(k) Applications for this Company
Contact	MARLENE A HANNA Other 510(k) Applications for this Contact
Regulation Number	866.5775   More FDA Info for this Regulation Number
Classification Product Code	DHR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/09/2004
Decision Date	09/20/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review