FDA 510(k) Application Details - K193419

Device Classification Name	More FDA Info for this Device
510(K) Number	K193419
Device Name	MBT Sepsityper
Applicant	Bruker Daltonik GmbH Fahrenheitstrasse 4 Bremen 28359 DE Other 510(k) Applications for this Company
Contact	Peter Trinder Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QNJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/09/2019
Decision Date	12/27/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review