Access Hybritech p2PSA Reagents on the Access Immunoassay Systems
FDA premarket approval P090026/S027 · decided 2020-03-17
Approval details
- PMA number
- P090026
- Supplement
- S027
- 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
- 2019-12-18
- Decision date
- 2020-03-17
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- OYA
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Chaska, MN
- Statement
- Approval for modification to the UniCel DxI Immunoassay Systems pick and place gantries.
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