|
Device | ACS: 180 AND ADVIA CENTAUR COMPLEXED PSA (CPSA) IMMUNOASSAYS |
Generic Name | ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA) |
Applicant | SIEMENS HEALTHCARE DIAGNOSTICS 333 CONEY STREET WALPOLE, MA 02032-1516 |
PMA Number | P990055 |
Supplement Number | S006 |
Date Received | 04/21/2003 |
Decision Date | 05/09/2003 |
Product Code |
NAF |
Advisory Committee |
Immunology |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR LABELING CHANGES TO THE ACS: 180 AND ADVIA CENTAUR COMPLEXED PSA (CPSA) IMMUNOASSAYS. |