PMA P120008S013
- Device
- Alinity i AFP Reagent Kit
- Applicant
- Abbott Laboratories
- Product code
- LOK
- Decision date
- 2020-06-05
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Approval order statement
- Approval of the release of the updated Alinity software.
Current openFDA PMA Record#
- Device
- Alinity i AFP Reagent Kit
- Applicant
- Abbott Laboratories
- PMA number
- P120008
- Supplement
- S013
- Product code
- LOK
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Decision date
- 2020-06-05
- Decision code
- APPR
- Date received
- 2020-03-09
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval of the release of the updated Alinity software.