PMA P950021S014
- Device
- ADVIA CENTAUR PSA ASSAY
- Applicant
- Siemens Healthcare Diagnostics
- PMA number
- P950021
- Supplement
- S014
- Product code
- MTF
- Decision date
- 2017-07-27
- Classification
- Total, Prostate Specific Antigen (noncomplexed & Complexed) For Detection Of Prostate Cancer
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Approval order statement
- Approval for the migration of the ADVIA Centaur PSA assay to the ADVIA Centaur XPT system
Current openFDA PMA Record#
- Device
- ADVIA CENTAUR PSA ASSAY
- Applicant
- Siemens Healthcare Diagnostics
- PMA number
- P950021
- Supplement
- S014
- Product code
- MTF
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Decision date
- 2017-07-27
- Decision code
- APPR
- Date received
- 2015-05-07
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for the migration of the ADVIA Centaur PSA assay to the ADVIA Centaur XPT system