|
Device | ADVIA CENTAUR XP SOFTWARE V6.0 ANTI-HCV |
Generic Name | Assay, enzyme linked immunosorbent, hepatitis c virus |
Applicant | SIEMENS HEALTHCARE DIAGNOSTICS 333 CONEY STREET WALPOLE, MA 02032-1516 |
PMA Number | P030056 |
Supplement Number | S006 |
Date Received | 05/18/2009 |
Decision Date | 08/19/2009 |
Reclassified Date
|
12/22/2021 |
Product Code |
MZO |
Advisory Committee |
Microbiology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE ADVIA CENTAUR XP SYSTEM SOFTWARE VERSION 6.0. |