FDA 510(k) Application Details - K001552

Device Classification Name	Enzyme Linked Immunoabsorption Assay, Treponema Pallidum   More FDA Info for this Device
510(K) Number	K001552
Device Name	Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Applicant	PHOENIX BIOTECH CORP. 53 CEDAR LAKE RD. BLAIRSTOWN, NJ 07825 US Other 510(k) Applications for this Company
Contact	Gary Lehnus 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	05/18/2000
Decision Date	10/19/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review