FDA 510(k) Application Details - K220178

Device Classification Name	Ige, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K220178
Device Name	Ige, Antigen, Antiserum, Control
Applicant	Beckman Coulter, Inc. 250 S. Kraemer Boulevard, Mail Stop B1.SE.03 Brea, CA 92821 US Other 510(k) Applications for this Company
Contact	Veronica Colinayo Other 510(k) Applications for this Contact
Regulation Number	866.5510   More FDA Info for this Regulation Number
Classification Product Code	DGC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/21/2022
Decision Date	03/23/2022
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