FDA.reportPublic FDA data

PMA P910007S064

Device
Alinity i Total PSA Reagent Kit
Applicant
Abbott Laboratories
PMA number
P910007
Supplement
S064
Product code
MTF
Decision date
2023-11-08
Classification
Immunology
Generic name
Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
Approval order statement
Approval for the release of Alinity i Total 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 Total PSA Reagent Kit
Applicant
Abbott Laboratories
PMA number
P910007
Supplement
S064
Product code
MTF
Generic name
Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
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 Total PSA for use with Alinity i (Alinity ci-series single and multimodule configuration) when connected to the GLP systems Track.