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Device | Atellica IM Prostate-Specific Antigen (PSA) Assay |
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 | S024 |
Date Received | 04/01/2021 |
Decision Date | 04/27/2021 |
Product Code |
MTG |
Advisory Committee |
Immunology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Moving manufacturing of Atellica IM analyzer’s component/subassembly named Autoloader to an internal supplier. |