|
Device | Alinity i Free PSA Reagent Kit |
Generic Name | Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions |
Applicant | Abbott Laboratories 100 ABBOTT PARK RD. AP5N-2 DEPT 09VB ABBOTT PARK, IL 60064-6070 |
PMA Number | P980007 |
Supplement Number | S053 |
Date Received | 08/11/2023 |
Decision Date | 11/08/2023 |
Product Code |
MTG |
Advisory Committee |
Immunology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
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. |