FDA 510(k) Application Details - K014233

Device Classification Name	Enzyme Linked Immunoabsorption Assay, Treponema Pallidum   More FDA Info for this Device
510(K) Number	K014233
Device Name	Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Applicant	TRINITY BIOTECH, PLC IDA BUSINESS PARK BRAY CO. WICKLOW IE Other 510(k) Applications for this Company
Contact	FIONA CAMPBELL 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	12/26/2001
Decision Date	01/24/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review