FDA 510(k) Application Details - K202541

Device Classification Name	Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody   More FDA Info for this Device
510(K) Number	K202541
Device Name	Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody
Applicant	Phadia AB Rapsgatan 7P P.O. Box 6460 Uppsala 751 37 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	NYO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/02/2020
Decision Date	09/13/2021
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