|
Device | DIMENSION TPSA FLEX REAGENT CARTRIDGE |
Generic Name | PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS |
Regulation Number | 866.6010 |
Applicant | SIEMENS HEALTHCARE DIAGNOSTICS 500 GBC DRIVE PO BOX 6101 NEWARK, DE 19714-6101 |
PMA Number | P000021 |
Supplement Number | S006 |
Date Received | 04/01/2005 |
Decision Date | 06/02/2005 |
Product Code |
LTJ |
Advisory Committee |
Immunology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE ADDITION OF THE STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULE TO THE DIMENSION RXL MAX. |