Siemens Healthcare Diagnostics Inc Glyn Rhonwy Llanberisgwynedd Ll55 4el Ll554 Pma Numberp930027 Supplement Numbers028 Date Received09 15 2022 Decision Date10 14 2022 Product Code Mtf 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 Healthcare Diagnostics Inc Glyn Rhonwy Llanberisgwynedd Ll55 4el Ll554 Pma Numberp930027 Supplement Numbers028 Date Received09 15 2022 Decision Date10 14 2022 Product Code Mtf 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 P930027S028 SIEMENS HEALTHCARE DIAGNOSTICS INC.glyn Rhonwy, Llanberisgwynedd Ll55 4el LL554 PMA NumberP930027 Supplement NumberS028 Date Received09/15/2022 Decision Date10/14/2022 Product Code MTF  Advisory Committee Immunology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	IMMULITE® /IMMULITE® 1000 PSA, IMMULITE® 2000 PSA and IMMULITE® /IMMULITE® 1000 Third Generation PSA	2022-10-14