FDA 510(k) Application Details - K023889

Device Classification Name	Enzyme Linked Immunosorbent Assay, T. Cruzi   More FDA Info for this Device
510(K) Number	K023889
Device Name	Enzyme Linked Immunosorbent Assay, T. Cruzi
Applicant	WIENER LABORATORIES S.A.I.C. 2944 RIOBAMBA ROSARIO 2000 AR Other 510(k) Applications for this Company
Contact	VIVIANA CETOLA 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	11/21/2002
Decision Date	02/11/2004
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