FDA 510(k) Applications for Medical Device Product Code: NBS (Autoantibodies,Lkm-1(Liver/Kidney Microsome,Type 1))

FDA 510(k) Applications for Medical Device Product Code "NBS"
(Autoantibodies,Lkm-1(Liver/Kidney Microsome,Type 1))

FDA 510(k) Number	Applicant	Device Name	Decision Date
K112223	EUROIMMUN US	EUROIMMUN ANTI-LKM-1 ELISA(LGG)	09/11/2012
K163538	INOVA DIAGNOSTICS, INC.	QUANTA Flash« LKM-1 Reagents, QUANTA Flash« LKM-1 Calibrators, QUANTA Flash« LKM-1 Controls	09/06/2017
K000535	INOVA DIAGNOSTICS, INC.	QUANTA LITE LKM-1 ELISA	06/07/2000