Access Hybritech p2PSA Reagents on the Access Immunoassay Systems
FDA premarket approval P090026/S031 · decided 2022-12-16
Approval details
- PMA number
- P090026
- Supplement
- S031
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Access Hybritech p2PSA Reagents on the Access Immunoassay Systems
- Generic name
- P2psa
- Applicant
- Beckman Coulter, Inc.
- Date received
- 2021-04-19
- Decision date
- 2022-12-16
- Days to decision
- 606 days
- Decision code
- APPR
- Product code
- OYA
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Chaska, MN
- Statement
- Approval for a modification to the UniCel DxI Immunoassay systems sample probe and reagent probe wash nozzle design using injection molding to reduce production cost.
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