FDA 510(k) Application Details - K221114

Device Classification Name	Method, Nephelometric, Immunoglobulins (G, A, M)   More FDA Info for this Device
510(K) Number	K221114
Device Name	Method, Nephelometric, Immunoglobulins (G, A, M)
Applicant	Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. No. 181 West Su Hong Road, Suzhou Industrial Park Suzhou 215021 CN Other 510(k) Applications for this Company
Contact	Tracy Jin Other 510(k) Applications for this Contact
Regulation Number	866.5510   More FDA Info for this Regulation Number
Classification Product Code	CFN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/15/2022
Decision Date	08/02/2023
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