PMA P120008S025
- Device
- Alinity i AFP
- Applicant
- Abbott Laboratories
- PMA number
- P120008
- Supplement
- S025
- Product code
- LOK
- Decision date
- 2023-09-25
- Classification
- Immunology
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Approval order statement
- Approval for the release of Alinity i AFP for use with Alinity ci-series.
Current openFDA PMA Record#
- Device
- Alinity i AFP
- Applicant
- Abbott Laboratories
- PMA number
- P120008
- Supplement
- S025
- Product code
- LOK
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Decision date
- 2023-09-25
- Decision code
- APPR
- Date received
- 2023-06-27
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the release of Alinity i AFP for use with Alinity ci-series.