Siemens Healthcare Diagnostics Products Ltdglyn Rhonwyllanberis Caernarfon Ll55 Pma Numberp010053 Supplement Numbers016 Date Received09 15 2022 Decision Date10 14 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 Products Ltdglyn Rhonwyllanberis Caernarfon Ll55 Pma Numberp010053 Supplement Numbers016 Date Received09 15 2022 Decision Date10 14 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 P010053S016 Siemens Healthcare Diagnostics Products, LTDglyn Rhonwyllanberis, Caernarfon LL55 PMA NumberP010053 Supplement NumberS016 Date Received09/15/2022 Decision Date10/14/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	IMMULITE® 2000 Anti-HBc IgM	2022-10-14