|
Device | DIMENSION FPSA FLEX REAGENT CARTRIDGE |
Generic Name | Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions |
Applicant | SIEMENS HEALTHCARE DIAGNOSTICS 500 GBC DRIVE, P O BOX 6101 M/S 514 NEWARK, DE 19714-6101 |
PMA Number | P020027 |
Supplement Number | S003 |
Date Received | 04/01/2005 |
Decision Date | 06/02/2005 |
Product Code |
MTG |
Advisory Committee |
Immunology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE ADDITION OF THE STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULE TO THE DIMENSION RXL MAX. |