FDA 510(k) Application Details - K072732

Device Classification Name	Enzyme Linked Immunosorbent Assay, T. Cruzi   More FDA Info for this Device
510(K) Number	K072732
Device Name	Enzyme Linked Immunosorbent Assay, T. Cruzi
Applicant	Ortho-Clinical Diagnostics, Inc. 1001 U.S. HWY. 202 RARITAN, NJ 08869-0606 US Other 510(k) Applications for this Company
Contact	ANDREA J CASPER Other 510(k) Applications for this Contact
Regulation Number	866.3870   More FDA Info for this Regulation Number
Classification Product Code	MIU Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/26/2007
Decision Date	04/15/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review