|
Device | ADVIA IMS PROSTATE SPECIFIC ANTIGEN ASSAY (PSA) |
Generic Name | ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA) |
Applicant | SIEMENS HEALTHCARE DIAGNOSTICS 333 CONEY STREET WALPOLE, MA 02032-1516 |
PMA Number | P990055 |
Supplement Number | S009 |
Date Received | 05/17/2006 |
Decision Date | 11/06/2006 |
Product Code |
NAF |
Advisory Committee |
Immunology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MANUFACTURING SITE CHANGE LOCATED AT FISHER DIAGNOSTICS, MIDDLETOWN, VIRGINIA. |