|
Device | ARCHITECT Total PSA Reagent/Calibrator/Control Kit |
Generic Name | Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer |
Applicant | Abbott Laboratories 100 ABBOTT PARK RD. ABBOTT PARK, IL 60064-3500 |
PMA Number | P910007 |
Supplement Number | S052 |
Date Received | 01/22/2019 |
Decision Date | 04/10/2020 |
Product Code |
MTF |
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 to implement of new lot of ARCHITECT Total PSA Secondary Calibrators A through F. |