|
Device | Access Hybritech PSA Reagents on the Access Immunoassay Systems |
Generic Name | Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer |
Applicant | BECKMAN COULTER, INC. 250 SOUTH KRAEMER BLVD M/S W-110 BREA, CA 92822 |
PMA Number | P850048 |
Supplement Number | S051 |
Date Received | 05/02/2019 |
Decision Date | 07/31/2019 |
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 for a modification to the UniCel Dxl System Software version 5.5.0 to remove a Y-like command that can result in sample sequencing errors for users who are connected to an automation line. |