PMA P090026S031

Device: Access Hybritech p2PSA Reagents on the Access Immunoassay Systems
Applicant: Beckman Coulter, Inc.
PMA number: P090026
Supplement: S031
Product code: OYA
Decision date: 2022-12-16
Generic name: P2psa
Approval order statement: Approval for a modification to the UniCel DxI Immunoassay system’s sample probe and reagent probe wash nozzle design using injection molding to reduce production cost.

Current openFDA PMA Record#

Device: Access Hybritech p2PSA Reagents on the Access Immunoassay Systems
Applicant: Beckman Coulter, Inc.
PMA number: P090026
Supplement: S031
Product code: OYA
Generic name: P2psa
Decision date: 2022-12-16
Decision code: APPR
Date received: 2021-04-19
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for a modification to the UniCel DxI Immunoassay system’s sample probe and reagent probe wash nozzle design using injection molding to reduce production cost.