Diasorin Inc1951 Northwestern Avenuestillwater Mn 55082 Pma Numberp190017 Supplement Numbers008 Date Received09 21 2022 Decision Date12 21 2022 Product Code Lom Advisory Committee Microbiology Supplement Typereal Time Process Supplement Reason Change Design Components Specifications Material Expedited Review Granted No

FDA Filings

This page includes the latest FDA filings for Diasorin Inc1951 Northwestern Avenuestillwater Mn 55082 Pma Numberp190017 Supplement Numbers008 Date Received09 21 2022 Decision Date12 21 2022 Product Code Lom Advisory Committee Microbiology Supplement Typereal Time Process Supplement Reason Change Design Components Specifications Material Expedited Review Granted No. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Filings

Device Company	Device	Date
PMA P190017S008 DiaSorin Inc1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP190017 Supplement NumberS008 Date Received09/21/2022 Decision Date12/21/2022 Product Code LOM  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No	LIAISON® XL MUREX HBsAg Qual, LIAISON® MUREX Control HBsAg, and LIAISON® XL MUREX HBsAg Confirmatory Test	2022-12-21