Siemens Healthcare Diagnostics Inc 511 Benedict Ave Tarrytown Ny 10591 Pma Numberp100039 Supplement Numbers015 Date Received03 22 2022 Decision Date03 29 2022 Product Code Lom Advisory Committee Microbiology 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 Numberp100039 Supplement Numbers015 Date Received03 22 2022 Decision Date03 29 2022 Product Code Lom Advisory Committee Microbiology 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 P100039S015 SIEMENS HEALTHCARE DIAGNOSTICS INC.511 Benedict Ave.tarrytown, NY 10591 PMA NumberP100039 Supplement NumberS015 Date Received03/22/2022 Decision Date03/29/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	Atellica® IM Anti-Hepatitis B surface Antigen 2 (aHBs2) Assay	2022-03-29