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Device | DIMENSION VISTA TPSA FLEX REAGENT CARTRIDGE FOR USE ON THE DIMENSION VISTA 500 SYSTEM |
Generic Name | Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer |
Applicant | SIEMENS HEALTHCARE DIAGNOSTICS 500 GBC DRIVE PO BOX 6101 NEWARK, DE 19714-6101 |
PMA Number | P000021 |
Supplement Number | S020 |
Date Received | 06/30/2011 |
Decision Date | 11/23/2011 |
Product Code |
MTF |
Advisory Committee |
Immunology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE DIMENSION VISTA TPSA FLEX REAGENT CARTRIDGE FOR USE ON THE DIMENSION VISTA 500 SYSTEM. |