PMA P990055S010
- Device
- ADVIA CENTAUR COMPLEXED (CPSA) & ADVIA CENTAUR CP CPSA IMMUNOASSAY
- Applicant
- Siemens Healthcare Diagnostics
- PMA number
- P990055
- Supplement
- S010
- Product code
- NAF
- Decision date
- 2009-12-03
- Classification
- Antigen(complexed),prostate Specific,(cpsa)
- Generic name
- ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA)
- Approval order statement
- APPROVAL FOR THE CHANGE IN ANTIBODY GROWTH MANUFACTURING PROCESS FROM ASCITES FLUID TO CELL CULTURE.
Current openFDA PMA Record#
- Device
- ADVIA CENTAUR COMPLEXED (CPSA) & ADVIA CENTAUR CP CPSA IMMUNOASSAY
- Applicant
- Siemens Healthcare Diagnostics
- PMA number
- P990055
- Supplement
- S010
- Product code
- NAF
- Generic name
- ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA)
- Decision date
- 2009-12-03
- Decision code
- APPR
- Date received
- 2009-03-06
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE CHANGE IN ANTIBODY GROWTH MANUFACTURING PROCESS FROM ASCITES FLUID TO CELL CULTURE.