FDA 510(k) Application Details - K242911

Device Classification Name	More FDA Info for this Device
510(K) Number	K242911
Device Name	Medconn Glycated Hemoglobin Test system
Applicant	Shanghai Medconn Medical Technology Co.,Ltd. No.1018 Weichang Road Shanyang Town, Jinshan District Shanghai 201508 CN Other 510(k) Applications for this Company
Contact	Judan Guan 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	09/24/2024
Decision Date	06/20/2025
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