PMA P950021S022
- Device
- ADVIA Centaur PSA Readypack Reagents
- Applicant
- Siemens Healthcare Diagnostics
- PMA number
- P950021
- Supplement
- S022
- Product code
- MTF
- Decision date
- 2020-08-25
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Approval order statement
- Procedure for testing raw materials, in-process and final products.
Current openFDA PMA Record#
- Device
- ADVIA Centaur PSA Readypack Reagents
- Applicant
- Siemens Healthcare Diagnostics
- PMA number
- P950021
- Supplement
- S022
- Product code
- MTF
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Decision date
- 2020-08-25
- Decision code
- OK30
- Date received
- 2020-07-31
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Procedure for testing raw materials, in-process and final products.