Alinity i Total PSA Reagent Kit
FDA premarket approval P910007/S064 · decided 2023-11-08
Approval details
- PMA number
- P910007
- Supplement
- S064
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Alinity i Total PSA Reagent Kit
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Applicant
- Abbott Laboratories
- Date received
- 2023-08-11
- Decision date
- 2023-11-08
- Days to decision
- 89 days
- Decision code
- APPR
- Product code
- MTF
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Abbott Park, IL
- Statement
- Approval for the release of Alinity i Total PSA for use with Alinity i (Alinity ci-series single and multimodule configuration) when connected to the GLP systems Track.
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