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Device | ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS |
Generic Name | P2psa |
Applicant | BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. CHASKA, MN 55318 |
PMA Number | P090026 |
Supplement Number | S010 |
Date Received | 12/17/2013 |
Decision Date | 05/01/2014 |
Product Code |
OYA |
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. |