FDA 510(k) Application Details - K163273

Device Classification Name	Legionella, Spp., Elisa   More FDA Info for this Device
510(K) Number	K163273
Device Name	Legionella, Spp., Elisa
Applicant	MERIDIAN BIOSCIENCE, INC. 3471 RIVER HILLS DRIVE CINCINNATI, OH 45244 US Other 510(k) Applications for this Company
Contact	Lauren Davis Other 510(k) Applications for this Contact
Regulation Number	866.3300   More FDA Info for this Regulation Number
Classification Product Code	MJH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/21/2016
Decision Date	02/21/2017
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