PMA P120008S027
- Device
- ARCHITECT AFP / Alinity i AFP
- Applicant
- Abbott Laboratories
- PMA number
- P120008
- Supplement
- S027
- Product code
- LOK
- Decision date
- 2023-12-14
- Classification
- Immunology
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Approval order statement
- a scale up of manufacturing processes for kit components
Current openFDA PMA Record#
- Device
- ARCHITECT AFP / Alinity i AFP
- Applicant
- Abbott Laboratories
- PMA number
- P120008
- Supplement
- S027
- Product code
- LOK
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Decision date
- 2023-12-14
- Decision code
- OK30
- Date received
- 2023-11-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a scale up of manufacturing processes for kit components