Access Hybritech PSA Reagents on the Access Immunoassay Systems
FDA premarket approval P850048/S057 · decided 2022-12-16
Approval details
- PMA number
- P850048
- Supplement
- S057
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Access Hybritech PSA Reagents on the Access Immunoassay Systems
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Applicant
- Beckman Coulter, Inc.
- Date received
- 2021-04-19
- Decision date
- 2022-12-16
- Days to decision
- 606 days
- Decision code
- APPR
- Product code
- MTF
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Brea, CA
- 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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