Beckman Coulter Inc 250 South Kraemer Blvd M Sw 110brea Ca 92822 Pma Numberp970038 Supplement Numbers045 Date Received04 19 2021 Decision Date12 16 2022 Product Code Mtg Advisory Committee Immunology Supplement Typereal Time Process Supplement Reason Change Design Components Specifications Material 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 Numberp970038 Supplement Numbers045 Date Received04 19 2021 Decision Date12 16 2022 Product Code Mtg Advisory Committee Immunology Supplement Typereal Time Process Supplement Reason Change Design Components Specifications Material 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 P970038S045 BECKMAN COULTER, INC.250 South Kraemer Blvd M/sw-110brea, CA 92822 PMA NumberP970038 Supplement NumberS045 Date Received04/19/2021 Decision Date12/16/2022 Product Code MTG  Advisory Committee Immunology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No	Access Hybritech Free PSA Reagents on the Access Immunoassay Systems	2022-12-16