Siemens Healthcare Diagnostics Inc 333 Coney Streeteast Walpole Ma 02032 Pma Numberp930036 Supplement Numbers019 Date Received03 22 2022 Decision Date03 29 2022 Product Code Lok Advisory Committee Immunology Supplement Type30 Day Notice Supplement Reason Process Change Manufacturer Sterilizer Packager Supplier Expedited Review Granted No

FDA Filings

This page includes the latest FDA filings for Siemens Healthcare Diagnostics Inc 333 Coney Streeteast Walpole Ma 02032 Pma Numberp930036 Supplement Numbers019 Date Received03 22 2022 Decision Date03 29 2022 Product Code Lok Advisory Committee Immunology Supplement Type30 Day Notice Supplement Reason Process Change Manufacturer Sterilizer Packager Supplier 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 P930036S019 SIEMENS HEALTHCARE DIAGNOSTICS INC.333 Coney Streeteast Walpole, MA 02032 PMA NumberP930036 Supplement NumberS019 Date Received03/22/2022 Decision Date03/29/2022 Product Code LOK  Advisory Committee Immunology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	Atellica® IM Alpha Fetoprotein (AFP) Assay	2022-03-29