FDA 510(k) Application Details - K250961

Device Classification Name	Tubes, Vials, Systems, Serum Separators, Blood Collection   More FDA Info for this Device
510(K) Number	K250961
Device Name	Tubes, Vials, Systems, Serum Separators, Blood Collection
Applicant	Promisemed Hangzhou Meditech Co., Ltd. No. 1388 Cangxing Street, Cangqian Community, Yuhang District Hangzhou City 311121 CN Other 510(k) Applications for this Company
Contact	Zearou Yang Other 510(k) Applications for this Contact
Regulation Number	862.1675   More FDA Info for this Regulation Number
Classification Product Code	JKA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/31/2025
Decision Date	06/04/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review