Siemens Medical Solutions Diagnostics Limitedglyn Rhonwy Llanberiscaernarfongwynedd Ll55 4el Pma Numberp060005 Supplement Numbers016 Date Received09 15 2022 Decision Date10 14 2022 Product Code Mtg 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 Medical Solutions Diagnostics Limitedglyn Rhonwy Llanberiscaernarfongwynedd Ll55 4el Pma Numberp060005 Supplement Numbers016 Date Received09 15 2022 Decision Date10 14 2022 Product Code Mtg 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 P060005S016 SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS LIMITEDglyn Rhonwy. Llanberiscaernarfongwynedd, Ll55 4EL PMA NumberP060005 Supplement NumberS016 Date Received09/15/2022 Decision Date10/14/2022 Product Code MTG  Advisory Committee Immunology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	IMMULITE® /IMMULITE® 1000 Free PSA and IMMULITE® 2000 Free PSA	2022-10-14