FDA 510(k) Application Details - K210902

Device Classification Name	Antinuclear Antibody, Antigen, Control   More FDA Info for this Device
510(K) Number	K210902
Device Name	Antinuclear Antibody, Antigen, Control
Applicant	Phadia AB Rapsgatan 7P Uppsala SE Other 510(k) Applications for this Company
Contact	Sheryl Skinner Other 510(k) Applications for this Contact
Regulation Number	866.5100   More FDA Info for this Regulation Number
Classification Product Code	LKJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/26/2021
Decision Date	07/27/2022
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