FDA 510(k) Application Details - K231045

Device Classification Name	Test, Urine Leukocyte   More FDA Info for this Device
510(K) Number	K231045
Device Name	Test, Urine Leukocyte
Applicant	Healgen Scientific LLC 5213 Maple St Bellaire, TX 77401 US Other 510(k) Applications for this Company
Contact	Jianqiu Fang Other 510(k) Applications for this Contact
Regulation Number	864.7675   More FDA Info for this Regulation Number
Classification Product Code	LJX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/12/2023
Decision Date	06/16/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review