FDA 510(k) Application Details - K211302

Device Classification Name	Enzyme Linked Immunoabsorption Assay, Treponema Pallidum   More FDA Info for this Device
510(K) Number	K211302
Device Name	Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Applicant	Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 US Other 510(k) Applications for this Company
Contact	Bin Sun 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	04/29/2021
Decision Date	07/20/2021
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