FDA 510(k) Application Details - K153730

Device Classification Name	Enzyme Linked Immunoabsorption Assay, Treponema Pallidum   More FDA Info for this Device
510(K) Number	K153730
Device Name	Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Applicant	Abbott Laboratories Dept 09AA, Bldg. AP 8, 100 Abbott Park Road Abbott Park, IL 60064-6038 US Other 510(k) Applications for this Company
Contact	Laura Yelvigi Joglekar 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	12/28/2015
Decision Date	06/15/2016
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