FDA 510(k) Application Details - K161297

Device Classification Name	System, Test, Beta-2-Microglobulin Immunological   More FDA Info for this Device
510(K) Number	K161297
Device Name	System, Test, Beta-2-Microglobulin Immunological
Applicant	Beckman Coulter Ireland Inc. Lismeehan, O'Callaghan's Mills Co. Clare IE Other 510(k) Applications for this Company
Contact	Eimear Carr Other 510(k) Applications for this Contact
Regulation Number	866.5630   More FDA Info for this Regulation Number
Classification Product Code	JZG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/09/2016
Decision Date	06/07/2016
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
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