Beckman Coulter Inc 1000 Lake Hazeltine Dr Chaska Mn 55318 Pma Numberp090026 Supplement Numbers031 Date Received04 19 2021 Decision Date12 16 2022 Product Code Oya 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 1000 Lake Hazeltine Dr Chaska Mn 55318 Pma Numberp090026 Supplement Numbers031 Date Received04 19 2021 Decision Date12 16 2022 Product Code Oya 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 P090026S031 BECKMAN COULTER, INC.1000 Lake Hazeltine Dr.chaska, MN 55318 PMA NumberP090026 Supplement NumberS031 Date Received04/19/2021 Decision Date12/16/2022 Product Code OYA  Advisory Committee Immunology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No	Access Hybritech p2PSA Reagents on the Access Immunoassay Systems	2022-12-16