PMA P120008S017

Device: ARCHITECT AFP Reagents, Alinity i AFP Reagent Kit
Applicant: Abbott Laboratories
PMA number: P120008
Supplement: S017
Product code: LOK
Decision date: 2021-04-22
Generic name: KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
Approval order statement: Approval to modify the ARCHITECT i1000SR probe wash with an alternate wash delivery system (AWDS), and to modify the ARCHITECT i2000SR and Alinity i with Induction Heating (IH)

Current openFDA PMA Record#

Device: ARCHITECT AFP Reagents, Alinity i AFP Reagent Kit
Applicant: Abbott Laboratories
PMA number: P120008
Supplement: S017
Product code: LOK
Generic name: KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
Decision date: 2021-04-22
Decision code: APPR
Date received: 2021-02-09
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval to modify the ARCHITECT i1000SR probe wash with an alternate wash delivery system (AWDS), and to modify the ARCHITECT i2000SR and Alinity i with Induction Heating (IH)