FDA 510(k) Application Details - K220999

Device Classification Name	More FDA Info for this Device
510(K) Number	K220999
Device Name	Hipro Glycosylated Hemoglobin (HbA1c) Test System
Applicant	Shijiazhuang Hipro Biotechnology Co., Ltd. No. 3 Building, Block C, Fangyi Science Park, No. 313 Zhujiangdadao Road, Hi-tech Zone Shijiazhuang 050000 CN Other 510(k) Applications for this Company
Contact	Emily No Last Name Provided Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PDJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/04/2022
Decision Date	09/12/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review