FDA 510(k) Application Details - K222771

Device Classification Name	More FDA Info for this Device
510(K) Number	K222771
Device Name	Sample Preservative Fluid
Applicant	Hangzhou Bioer Technology Co., LTD 1192 BinAn Rd Hangzhou 310053 CN Other 510(k) Applications for this Company
Contact	Zoey . 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	09/14/2022
Decision Date	06/26/2024
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