FDA 510(k) Application Details - K230035

Device Classification Name	Culture Media, Non-Propagating Transport   More FDA Info for this Device
510(K) Number	K230035
Device Name	Culture Media, Non-Propagating Transport
Applicant	Shenzhen Dakewe Bio-engineering Co., Ltd. Room 702-703, Building No.1,Shenzhen Biomedicine Innovations Industrial Park, No.14 Jinhui Road, Kengzi Street, Pingshan Shenzhen 518122 CN Other 510(k) Applications for this Company
Contact	Jiang Wei 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	01/05/2023
Decision Date	04/05/2023
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