FDA 510(k) Application Details - K190613

Device Classification Name	More FDA Info for this Device
510(K) Number	K190613
Device Name	BD MAX Check-Points CPO
Applicant	Check-Points Health B.V. Binnenhaven 5 Wageningen 6709 NL Other 510(k) Applications for this Company
Contact	Pieter Vos Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	POC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/11/2019
Decision Date	08/29/2019
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