|
Device | IMMULITE/IMMULITE 1000 & IMMULITE 2000 FREE PSA |
Generic Name | Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions |
Applicant | SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS LIMITED GLYN RHONWY. LLANBERIS CAERNARFON GWYNEDD, LL55 4EL |
PMA Number | P060005 |
Supplement Number | S001 |
Date Received | 11/10/2008 |
Decision Date | 12/30/2008 |
Product Code |
MTG |
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 LOCATED AT SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LIMITED, GWYNEDD, UNITED KINGDOM. |