DIMENSION TPSA FLEX REAGENT CARTRIDGE
FDA premarket approval P000021/S023 · decided 2013-02-22
Approval details
- PMA number
- P000021
- Supplement
- S023
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- DIMENSION TPSA FLEX REAGENT CARTRIDGE
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Applicant
- Siemens Healthcare Diagnostics
- Date received
- 2012-03-20
- Decision date
- 2013-02-22
- Days to decision
- 339 days
- Decision code
- APPR
- Product code
- MTF
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Newark, DE
- 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.
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