ADVIA CENTAUR PSA ASSAY
FDA premarket approval P950021/S014 · decided 2017-07-27
Approval details
- PMA number
- P950021
- Supplement
- S014
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ADVIA CENTAUR PSA ASSAY
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Applicant
- Siemens Healthcare Diagnostics
- Date received
- 2015-05-07
- Decision date
- 2017-07-27
- Days to decision
- 812 days
- Decision code
- APPR
- Product code
- MTF
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- East Walpole, MA
- Statement
- Approval for the migration of the ADVIA Centaur PSA assay to the ADVIA Centaur XPT system
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