FDA 510(k) Application Details - K231027

Device Classification Name	Culture Media, Non-Propagating Transport   More FDA Info for this Device
510(K) Number	K231027
Device Name	Culture Media, Non-Propagating Transport
Applicant	Hangzhou Genesis Biodetection & Biocontrol Co., Ltd. #139 10th Street (East) Hangzhou Economic And Technology Development Zone Hangzhou 310018 CN Other 510(k) Applications for this Company
Contact	Guan Emma 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	04/11/2023
Decision Date	12/21/2023
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