PMA P120008S022

Device: ARCHITECT AFP, Alinity i AFP
Applicant: Abbott Laboratories
PMA number: P120008
Supplement: S022
Product code: LOK
Decision date: 2023-10-11
Classification: Immunology
Generic name: KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
Approval order statement: Approval for the formulation change for the common accessories, Pre-Trigger and Trigger, and storage condition changes for Pre-Trigger used on ARCHITECT i2000SR, ARCHITECT i1000SR and Alinity i analyzer

Current openFDA PMA Record#

Device: ARCHITECT AFP, Alinity i AFP
Applicant: Abbott Laboratories
PMA number: P120008
Supplement: S022
Product code: LOK
Generic name: KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
Decision date: 2023-10-11
Decision code: APPR
Date received: 2023-02-16
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for the formulation change for the common accessories, Pre-Trigger and Trigger, and storage condition changes for Pre-Trigger used on ARCHITECT i2000SR, ARCHITECT i1000SR and Alinity i analyzer