|
Device | IMMULITE/IMMULITE 1000 PSA & 1000 THIRD GENERATION PSA |
Generic Name | PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS |
Regulation Number | 866.6010 |
Applicant | SIEMENS HEALTHCARE DIAGNOSTICS INC. GLYN RHONWY, LLANBERIS GWYNEDD LL55 4EL LL554 |
PMA Number | P930027 |
Supplement Number | S005 |
Date Received | 01/21/2003 |
Decision Date | 02/28/2003 |
Product Code |
LTJ |
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 ADDITION OF THE IMMULITE 1000 ANALYZER TO THE ANALYZERS USED FOR THE IMMULITE PSA AND IMMULITE THIRD GENERATION PSA ASSAYS. |