FDA 510(k) Application Details - K232317

Device Classification Name	Blood, Occult, Colorimetric, In Urine   More FDA Info for this Device
510(K) Number	K232317
Device Name	Blood, Occult, Colorimetric, In Urine
Applicant	URIT Medical Electronic Co., Ltd. NO. D-07 Information Industry District, High-Tech Zone, Guilin, Guangxi 541004, P.R.China Guilin 541004 CN Other 510(k) Applications for this Company
Contact	Jiang Jun Other 510(k) Applications for this Contact
Regulation Number	864.6550   More FDA Info for this Regulation Number
Classification Product Code	JIO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/03/2023
Decision Date	04/26/2024
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