Access Hybritech PSA Reagents on the Access Immunoassay Systems
FDA premarket approval P850048/S053 · decided 2020-03-17
Approval details
- PMA number
- P850048
- Supplement
- S053
- 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
- 2019-12-18
- Decision date
- 2020-03-17
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- MTF
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Brea, CA
- Statement
- Approval for modification to the UniCel DxI Immunoassay Systems pick and place gantries.
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