|
Device | ADVIA CENTAUR COMPLEXED (CPSA) & ADVIA CENTAUR CP CPSA IMMUNOASSAY |
Generic Name | ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA) |
Applicant | SIEMENS HEALTHCARE DIAGNOSTICS 333 CONEY STREET WALPOLE, MA 02032-1516 |
PMA Number | P990055 |
Supplement Number | S010 |
Date Received | 03/06/2009 |
Decision Date | 12/03/2009 |
Product Code |
NAF |
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 THE CHANGE IN ANTIBODY GROWTH MANUFACTURING PROCESS FROM ASCITES FLUID TO CELL CULTURE. |