|
Device | ADVIA Centaur PSA Readypack Reagents |
Generic Name | Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer |
Applicant | SIEMENS HEALTHCARE DIAGNOSTICS 333 CONEY STREET WALPOLE, MA 02032-1516 |
PMA Number | P950021 |
Supplement Number | S022 |
Date Received | 07/31/2020 |
Decision Date | 08/25/2020 |
Product Code |
MTF |
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 Procedure for testing raw materials, in-process and final products. |