FDA 510(k) Application Details - K222141

Device Classification Name	Tubes, Vials, Systems, Serum Separators, Blood Collection   More FDA Info for this Device
510(K) Number	K222141
Device Name	Tubes, Vials, Systems, Serum Separators, Blood Collection
Applicant	Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. No. 2 Guanyin Road, Economic Development Zone, Taihu Anqing 246400 CN Other 510(k) Applications for this Company
Contact	Bingyi Xiang 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	07/20/2022
Decision Date	10/21/2022
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