FDA 510(k) Application Details - K212856

Device Classification Name	Culture Media, Non-Propagating Transport   More FDA Info for this Device
510(K) Number	K212856
Device Name	Culture Media, Non-Propagating Transport
Applicant	Huachenyang (Shenzhen) Technology Co. Ltd. F8/Bldg 4, Hengchangrong High Industrial Park, No.128 East Road, Shang Nan Shenzhen 518103 CN Other 510(k) Applications for this Company
Contact	Robin Chu 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	09/08/2021
Decision Date	08/18/2022
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	Y
Expedited Review