Siemens Medical Solutions Diagnostics Limitedglyn Rhonwy Llanberiscaernarfongwynedd Ll55 4el Pma Numberp060005 Supplement Numbers014 Date Received02 28 2022 Decision Date03 29 2022 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 Numbers014 Date Received02 28 2022 Decision Date03 29 2022 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 P060005S014 SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS LIMITEDglyn Rhonwy. Llanberiscaernarfongwynedd, Ll55 4EL PMA NumberP060005 Supplement NumberS014 Date Received02/28/2022 Decision Date03/29/2022 Advisory Committee Immunology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	IMMULITE / IMMULITE 1000 Free PSA, IMMULITE 2000 Free PSA	2022-03-29