FDA 510(k) Application Details - K232587

Device Classification Name	System, Test, Vitamin D   More FDA Info for this Device
510(K) Number	K232587
Device Name	System, Test, Vitamin D
Applicant	Shenzhen New Industries Biomedical Engineering Co., Ltd No.16, Jinhui Road, Pingshan New District Shenzhen 518122 CN Other 510(k) Applications for this Company
Contact	Xiaoli Wang Other 510(k) Applications for this Contact
Regulation Number	862.1825   More FDA Info for this Regulation Number
Classification Product Code	MRG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/25/2023
Decision Date	04/12/2024
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