|
Device | ARCHITECT Total PSA Reagent Kit, Alinity i Total PSA Reagent 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 | S055 |
Date Received | 02/09/2021 |
Decision Date | 04/22/2021 |
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 modify the ARCHITECT i1000SR probe wash with an alternate wash delivery system (AWDS), and to modify the ARCHITECT i2000SR and Alinity i with Induction Heating (IH). |