Beckman Coulter Inc 250 South Kraemer Blvd M Sw 110brea Ca 92822 Pma Numberp850048 Supplement Numbers058 Date Received02 04 2022 Decision Date03 03 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 Beckman Coulter Inc 250 South Kraemer Blvd M Sw 110brea Ca 92822 Pma Numberp850048 Supplement Numbers058 Date Received02 04 2022 Decision Date03 03 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 P850048S058 BECKMAN COULTER, INC.250 South Kraemer Blvd M/sw-110brea, CA 92822 PMA NumberP850048 Supplement NumberS058 Date Received02/04/2022 Decision Date03/03/2022 Product Code MTF  Advisory Committee Immunology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	Access Hybritech PSA Reagents on the Access Immunoassay Systems	2022-03-03