DIMENSION VISTA TPSA ASSAY
FDA premarket approval P000021/S028 · decided 2016-10-19
Approval details
- PMA number
- P000021
- Supplement
- S028
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- DIMENSION VISTA TPSA ASSAY
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Applicant
- Siemens Healthcare Diagnostics
- Date received
- 2015-12-07
- Decision date
- 2016-10-19
- Days to decision
- 317 days
- Decision code
- APPR
- Product code
- MTF
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Newark, DE
- Statement
- Approval for a device modification to add a new photomultiplier tube (PMT) to the Dimension Vista 1500 and 500 Systems.
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