PMA P980007S053

Device: Alinity i Free PSA Reagent Kit
Applicant: Abbott Laboratories
PMA number: P980007
Supplement: S053
Product code: MTG
Decision date: 2023-11-08
Classification: Immunology
Generic name: Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
Approval order statement: Approval for the release of Alinity i Free PSA 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 Free PSA Reagent Kit
Applicant: Abbott Laboratories
PMA number: P980007
Supplement: S053
Product code: MTG
Generic name: Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
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 Free PSA for use with Alinity i (Alinity ci-series single and multimodule configuration) when connected to the GLP systems Track.