FDA 510(k) Application Details - K220908

Device Classification Name	Culture Media, Non-Propagating Transport   More FDA Info for this Device
510(K) Number	K220908
Device Name	Culture Media, Non-Propagating Transport
Applicant	Ensol Biosciences Inc. 51, Techno 10-ro, Yuseong-gu Daejeon 34036 KR Other 510(k) Applications for this Company
Contact	Cheol-Min Lee 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	03/29/2022
Decision Date	08/29/2024
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