PMA P120008S032
- Device
- ARCHITECT AFP; Alinity i AFP (LN 3P36/07P90)
- Applicant
- Abbott Laboratories
- PMA number
- P120008
- Supplement
- S032
- Product code
- LOK
- Decision date
- 2026-05-11
- Classification
- Immunology
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Approval order statement
- Approval of changes in testing requirements of reference materials.
Current openFDA PMA Record#
- Device
- ARCHITECT AFP; Alinity i AFP (LN 3P36/07P90)
- Applicant
- Abbott Laboratories
- PMA number
- P120008
- Supplement
- S032
- Product code
- LOK
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Decision date
- 2026-05-11
- Decision code
- OK30
- Date received
- 2026-04-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval of changes in testing requirements of reference materials.