PMA P120008S019
- Device
- ARCHITECT AFP / Alinity i AFP
- Applicant
- Abbott Laboratories
- PMA number
- P120008
- Supplement
- S019
- Product code
- LOK
- Decision date
- 2021-12-17
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Approval order statement
- Change a raw material supplier.
Current openFDA PMA Record#
- Device
- ARCHITECT AFP / Alinity i AFP
- Applicant
- Abbott Laboratories
- PMA number
- P120008
- Supplement
- S019
- Product code
- LOK
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Decision date
- 2021-12-17
- Decision code
- OK30
- Date received
- 2021-11-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change a raw material supplier.