PMA P990055S015
- Device
- ADVIA CENTAUR CPSA ASSAY
- Applicant
- Siemens Healthcare Diagnostics
- PMA number
- P990055
- Supplement
- S015
- Product code
- NAF
- Decision date
- 2016-10-24
- Classification
- Antigen(complexed),prostate Specific,(cpsa)
- Generic name
- ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA)
- Approval order statement
- Approval for the migration of the ADVIA Centaur cPSA assay to the ADVIA Centaur XPT system
Current openFDA PMA Record#
- Device
- ADVIA CENTAUR CPSA ASSAY
- Applicant
- Siemens Healthcare Diagnostics
- PMA number
- P990055
- Supplement
- S015
- Product code
- NAF
- Generic name
- ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA)
- Decision date
- 2016-10-24
- 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 cPSA assay to the ADVIA Centaur XPT system