FDA 510(k) Application Details - K233663

Device Classification Name	Method, Nephelometric, Immunoglobulins (G, A, M)   More FDA Info for this Device
510(K) Number	K233663
Device Name	Method, Nephelometric, Immunoglobulins (G, A, M)
Applicant	Siemens Healthcare Diagnostics Products GmbH Emil-von-Behring-Str. 76 Marburg 35041 DE Other 510(k) Applications for this Company
Contact	Sanja Matern 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	11/15/2023
Decision Date	12/13/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review