FDA 510(k) Application Details - K234052

Device Classification Name	Radioimmunoassay (Two-Site Solid Phase), Ferritin   More FDA Info for this Device
510(K) Number	K234052
Device Name	Radioimmunoassay (Two-Site Solid Phase), Ferritin
Applicant	Beckman Coulter, Inc 1000 Lake Hazeltine Drive Chaska, MN 55318 US Other 510(k) Applications for this Company
Contact	Kate Oelberg Other 510(k) Applications for this Contact
Regulation Number	866.5340   More FDA Info for this Regulation Number
Classification Product Code	JMG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/21/2023
Decision Date	03/20/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review