Access Hybritech Free PSA Reagents on the Access Immunoassay Systems
FDA premarket approval P970038/S039 · decided 2019-07-31
Approval details
- PMA number
- P970038
- Supplement
- S039
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Access Hybritech Free PSA Reagents on the Access Immunoassay Systems
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Applicant
- Beckman Coulter, Inc.
- Date received
- 2019-05-02
- Decision date
- 2019-07-31
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- MTG
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Brea, CA
- Statement
- Approval for a modification to the UniCel Dxl System Software version 5.5.0 to remove a Y-like command that can result in sample sequencing errors for users who are connected to an automation line.
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