FDA 510(k) Application Details - K163436

Device Classification Name	Culture Media, Non-Propagating Transport   More FDA Info for this Device
510(K) Number	K163436
Device Name	Culture Media, Non-Propagating Transport
Applicant	GREINER BIO-ONE NA INC. 4238 CAPITAL DRIVE MONROE, NC 28110 US Other 510(k) Applications for this Company
Contact	MANFRED ABEL Other 510(k) Applications for this Contact
Regulation Number	866.2390   More FDA Info for this Regulation Number
Classification Product Code	JSM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/07/2016
Decision Date	03/06/2017
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