PMA P090026S026

Device: Access Hybritech p2PSA Reagents on the Access Immunoassay Systems
Applicant: Beckman Coulter, Inc.
PMA number: P090026
Supplement: S026
Product code: OYA
Decision date: 2019-08-09
Classification: P2psa
Generic name: P2psa
Approval order statement: Approval for a modification to the piston rod design in the vacuum pump of the UniCel DxI 600 and 800 instruments, integrating the washer and piston rod into a single unit.

Current openFDA PMA Record#

Device: Access Hybritech p2PSA Reagents on the Access Immunoassay Systems
Applicant: Beckman Coulter, Inc.
PMA number: P090026
Supplement: S026
Product code: OYA
Generic name: P2psa
Decision date: 2019-08-09
Decision code: APPR
Date received: 2019-05-13
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for a modification to the piston rod design in the vacuum pump of the UniCel DxI 600 and 800 instruments, integrating the washer and piston rod into a single unit.