PMA P120008S026

Device: Alinity i AFP Reagent Kit
Applicant: Abbott Laboratories
PMA number: P120008
Supplement: S026
Product code: LOK
Decision date: 2023-11-08
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 i (Alinity ci-series single and multimodule configuration) when connected to the GLP systems Track.

Current openFDA PMA Record#

Device: Alinity i AFP Reagent Kit
Applicant: Abbott Laboratories
PMA number: P120008
Supplement: S026
Product code: LOK
Generic name: KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
Decision date: 2023-11-08
Decision code: APPR
Date received: 2023-08-11
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 i (Alinity ci-series single and multimodule configuration) when connected to the GLP systems Track.