FDA 510(k) Application Details - K191184

Device Classification Name	Legionella, Spp., Elisa   More FDA Info for this Device
510(K) Number	K191184
Device Name	Legionella, Spp., Elisa
Applicant	SSI Diagnostica A/S 2 Herredsvejen Hilleroed 3400 DK Other 510(k) Applications for this Company
Contact	Pernille Landsbo Elverdal 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	05/03/2019
Decision Date	03/05/2020
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