Siemens Healthcare Diagnostics333 Coney Streetwalpole Ma 02032 1516 Pma Numberp040004 Supplement Numbers021 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 Diagnostics333 Coney Streetwalpole Ma 02032 1516 Pma Numberp040004 Supplement Numbers021 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 P040004S021 SIEMENS HEALTHCARE DIAGNOSTICS333 Coney Streetwalpole, MA 02032-1516 PMA NumberP040004 Supplement NumberS021 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 core Total (HBcT) Assay	2022-03-29