FDA 510(k) Application Details - K241423

Device Classification Name	System,Test,Thyroglobulin   More FDA Info for this Device
510(K) Number	K241423
Device Name	System,Test,Thyroglobulin
Applicant	Beckman Coulter, Inc 1000 Lake Hazeltine Dr Chaska, MN 55318 US Other 510(k) Applications for this Company
Contact	Muhammad Sheikh Other 510(k) Applications for this Contact
Regulation Number	866.6010   More FDA Info for this Regulation Number
Classification Product Code	MSW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/20/2024
Decision Date	06/07/2024
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