PMA P090026S022

Device: Access Hybritech p2PSA Reagents on the Access Immunoassay Systems
Applicant: Beckman Coulter, Inc.
PMA number: P090026
Supplement: S022
Product code: OYA
Decision date: 2018-12-21
Classification: P2psa
Generic name: P2psa
Approval order statement: Approval for a modification to the Unicel Dxl Clinical System's reagent pipettor gantry and to the reagent vessel carriage by changing the carriage motor and carriage rail suppliers to simplify the design resulting in improvements to manufacturability, service and assembly and cost reduction.

Current openFDA PMA Record#

Device: Access Hybritech p2PSA Reagents on the Access Immunoassay Systems
Applicant: Beckman Coulter, Inc.
PMA number: P090026
Supplement: S022
Product code: OYA
Generic name: P2psa
Decision date: 2018-12-21
Decision code: APPR
Date received: 2018-09-25
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for a modification to the Unicel Dxl Clinical System's reagent pipettor gantry and to the reagent vessel carriage by changing the carriage motor and carriage rail suppliers to simplify the design resulting in improvements to manufacturability, service and assembly and cost reduction.