FDA 510(k) Application Details - K001525

Device Classification Name	Enzyme Linked Immunoabsorption Assay, Treponema Pallidum   More FDA Info for this Device
510(K) Number	K001525
Device Name	Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Applicant	TRINITY BIOTECH, PLC PO BOX 1059, 2823 GIRTS RD. JAMESTOWN, NY 14702-1059 US Other 510(k) Applications for this Company
Contact	WAYNE KVETKOSKY Other 510(k) Applications for this Contact
Regulation Number	866.3830   More FDA Info for this Regulation Number
Classification Product Code	LIP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/16/2000
Decision Date	11/29/2000
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