PMA P090026S025

Device: Access Hybritech p2PSA Reagents on the Access Immunoassay Systems
Applicant: Beckman Coulter, Inc.
PMA number: P090026
Supplement: S025
Product code: OYA
Decision date: 2019-07-31
Classification: P2psa
Generic name: P2psa
Approval order statement: Approval for a modification to the UniCel Dxl System Software version 5.5.0 to remove a Y-like command that can result in sample sequencing errors for users who are connected to an automation line.

Current openFDA PMA Record#

Device: Access Hybritech p2PSA Reagents on the Access Immunoassay Systems
Applicant: Beckman Coulter, Inc.
PMA number: P090026
Supplement: S025
Product code: OYA
Generic name: P2psa
Decision date: 2019-07-31
Decision code: APPR
Date received: 2019-05-02
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for a modification to the UniCel Dxl System Software version 5.5.0 to remove a Y-like command that can result in sample sequencing errors for users who are connected to an automation line.