Siemens Healthcare Diagnostics Inc 511 Benedict Ave Tarrytown Ny 10591 Pma Numberp010007 Supplement Numbers017 Date Received09 15 2022 Decision Date10 14 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 511 Benedict Ave Tarrytown Ny 10591 Pma Numberp010007 Supplement Numbers017 Date Received09 15 2022 Decision Date10 14 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 P010007S017 SIEMENS HEALTHCARE DIAGNOSTICS INC.511 Benedict Ave.tarrytown, NY 10591 PMA NumberP010007 Supplement NumberS017 Date Received09/15/2022 Decision Date10/14/2022 Product Code LOK  Advisory Committee Immunology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	IMMULITE® /IMMULITE® 1000 AFP and IMMULITE® 2000 AFP	2022-10-14