FDA 510(k) Application Details - K240800

Device Classification Name	Radioassay, Intrinsic Factor Blocking Antibody   More FDA Info for this Device
510(K) Number	K240800
Device Name	Radioassay, Intrinsic Factor Blocking Antibody
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	862.1810   More FDA Info for this Regulation Number
Classification Product Code	LIG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/25/2024
Decision Date	05/03/2024
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