FDA 510(k) Application Details - K191967

Device Classification Name	More FDA Info for this Device
510(K) Number	K191967
Device Name	Unyvero LRT BAL Application
Applicant	Curetis GmbH Max-Eyth-Stra▀e 42 Holzgerlingen 71088 DE Other 510(k) Applications for this Company
Contact	Karsten Mueller Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QBH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/23/2019
Decision Date	12/20/2019
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