FDA 510(k) Application Details - K223503

Device Classification Name	System, Test, Vitamin D   More FDA Info for this Device
510(K) Number	K223503
Device Name	System, Test, Vitamin D
Applicant	Beckman Coulter Inc 1000 Lake Hazeltine Drive Chaska, MN 55318-1084 US Other 510(k) Applications for this Company
Contact	Kate Oelberg 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	11/22/2022
Decision Date	01/19/2023
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