|
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 | S037 |
Date Received | 12/17/2013 |
Decision Date | 05/01/2014 |
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 SOFTWARE CHANGES TO ADD PROCESS MONITORING FUNCTIONALITY TO THE CURRENT CONFIGURATION OF THE ACCESS 2 IMMUNOASSAY SYSTEM THROUGH THE IMPLEMENTATION OF A NEW SOFTWARE VERSION 3.4.1. |