FDA 510(k) Applications for Medical Device Product Code: PZJ ()

FDA 510(k) Applications for Medical Device Product Code "PZJ"

FDA 510(k) Number	Applicant	Device Name	Decision Date
K211181	Biocartis NV	Idylla MSI Test	02/27/2023
K213348	Leica Biosystems Newcastle, Ltd.	BOND MMR Antibody Panel	02/21/2023
K200129	Promega Corporation	OncoMate MSI Dx Analysis System	07/26/2021
DEN170030	Ventana Medical Systems	VENTANA anti-MLH-1(M1) Mouse Monoclonal Primary Antibody, VENTANA anti-PMS2 (A16-4) Mouse Monoclonal Primary Antibody, VENTANA anti-MSH2 (G219-1129) Mouse Monoclonal Primary Antibody, VENTANA anti-MSH6 (SP 93) Mouse Monoclonal Primary Antibody, VENTANA a	10/27/2017