FDA 510(k) Application Details - K240182

Device Classification Name	Assay, Erythropoietin   More FDA Info for this Device
510(K) Number	K240182
Device Name	Assay, Erythropoietin
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	864.7250   More FDA Info for this Regulation Number
Classification Product Code	GGT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/23/2024
Decision Date	04/22/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review