PMA P120008S014

Device: Alinity i AFP
Applicant: Abbott Laboratories
PMA number: P120008
Supplement: S014
Product code: LOK
Decision date: 2020-05-23
Generic name: KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
Approval order statement: Approval for a manufacturing site located at Abbott Laboratories, 1915 Hurd Drive, Irving, Texas 75038, USA for the production of the Alinity i System.

Current openFDA PMA Record#

Device: Alinity i AFP
Applicant: Abbott Laboratories
PMA number: P120008
Supplement: S014
Product code: LOK
Generic name: KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
Decision date: 2020-05-23
Decision code: APPR
Date received: 2020-03-16
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for a manufacturing site located at Abbott Laboratories, 1915 Hurd Drive, Irving, Texas 75038, USA for the production of the Alinity i System.