|
Device | Advia Centaur PSA Immunoassay and Atellica IM PSA Immunoassay |
Generic Name | Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions |
Applicant | SIEMENS HEALTHCARE DIAGNOSTICS 333 CONEY STREET WALPOLE, MA 02032-1516 |
PMA Number | P950021 |
Supplement Number | S019 |
Date Received | 09/19/2019 |
Decision Date | 07/02/2020 |
Product Code |
MTG |
Advisory Committee |
Immunology |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the implementation of a new model luminometer utilized in the in-process testing of Lite Reagent components. |