PMA P950021S015
- Device
- Atellica IM Prostate-Specific Antigen (PSA)
- Applicant
- Siemens Healthcare Diagnostics
- PMA number
- P950021
- Supplement
- S015
- Product code
- MTF
- Decision date
- 2018-08-03
- 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 of the migration of the ADVIA Centaur PSA Assay to the Atellica IM Analyzer.
Current openFDA PMA Record#
- Device
- Atellica IM Prostate-Specific Antigen (PSA)
- Applicant
- Siemens Healthcare Diagnostics
- PMA number
- P950021
- Supplement
- S015
- Product code
- MTF
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Decision date
- 2018-08-03
- Decision code
- APPR
- Date received
- 2017-08-01
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval of the migration of the ADVIA Centaur PSA Assay to the Atellica IM Analyzer.