Siemens Healthcare Diagnostics Inc Glyn Rhonwy Llanberisgwynedd Ll55 4el Ll554 Pma Numberp930027 Supplement Numbers026 Date Received02 28 2022 Decision Date03 29 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 Numbers026 Date Received02 28 2022 Decision Date03 29 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 P930027S026 SIEMENS HEALTHCARE DIAGNOSTICS INC.glyn Rhonwy, Llanberisgwynedd Ll55 4el LL554 PMA NumberP930027 Supplement NumberS026 Date Received02/28/2022 Decision Date03/29/2022 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, IMMULITE/IMMULITE 1000 Third Generation PSA	2022-03-29