FDA 510(k) Application Details - K201674

Device Classification Name	Culture Media, Non-Propagating Transport   More FDA Info for this Device
510(K) Number	K201674
Device Name	Culture Media, Non-Propagating Transport
Applicant	Merit Medical Systems, Inc 1600 West Merit Parkway South Jordan, UT 84095 US Other 510(k) Applications for this Company
Contact	Alex Bohorquez 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	06/19/2020
Decision Date	03/03/2021
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