FDA 510(k) Application Details - K220059

Device Classification Name	More FDA Info for this Device
510(K) Number	K220059
Device Name	BiosciÖ Inactivated Transport Medium, BiosciÖ ITM
Applicant	Shenzhen Dakewe Bio-engineering Co., Ltd. No.14 Jinhui Road, Kengzi Street, Pingshan District Shenzhen 518122 CN Other 510(k) Applications for this Company
Contact	Wei Jiang Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QBD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/10/2022
Decision Date	01/19/2023
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