PMA P950021S020
- Device
- ADVIA Centaur and Atellica IM PSA
- Applicant
- Siemens Healthcare Diagnostics
- PMA number
- P950021
- Supplement
- S020
- Product code
- MTF
- Decision date
- 2020-03-19
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Approval order statement
- Scale-up and implementation of a common mixing process for all kit bulk reagents.
Current openFDA PMA Record#
- Device
- ADVIA Centaur and Atellica IM PSA
- Applicant
- Siemens Healthcare Diagnostics
- PMA number
- P950021
- Supplement
- S020
- Product code
- MTF
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Decision date
- 2020-03-19
- Decision code
- OK30
- Date received
- 2020-02-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Scale-up and implementation of a common mixing process for all kit bulk reagents.