FDA 510(k) Applications for Medical Device Product Code: NYO (Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody)

FDA 510(k) Applications for Medical Device Product Code "NYO"
(Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K172078	IMMCO Diagnostics, Inc.	ImmuLisa Enhanced RNA POL III Antibody ELISA	03/30/2018
K070066	INOVA DIAGNOSTICS, INC.	QUANTA LITE RNA POL III ELISA	04/11/2007
K060431	MBL INTERNATIONAL CORPORATION	ANTI RNA POLYMERASE III ELISA KIT, MODEL 7805	06/19/2006
K202541	Phadia AB	EliA RNA Pol III	09/13/2021