|
Device | DIMENSION TPSA FLEX REAGENT CARTRIDGE |
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 | S023 |
Date Received | 03/20/2012 |
Decision Date | 02/22/2013 |
Product Code |
MTF |
Advisory Committee |
Immunology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR A SOFTWARE REVISION THAT CHANGES THE OPERATING SYSTEM OF THE INSTRUMENT FROM THE CURRENT QNX OPERATING SYSTEM TO THE LINUX OPERATING SYSTEM AND ADDRESSES HARDWARE OBSOLESCENCE ISSUES. |