PMA P990055S011
- Device
- ADVIA CENTAUR PSA & CPSA ASSAYS
- Applicant
- Siemens Healthcare Diagnostics
- PMA number
- P990055
- Supplement
- S011
- Product code
- NAF
- Decision date
- 2009-03-06
- Classification
- Antigen(complexed),prostate Specific,(cpsa)
- Generic name
- ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA)
- Approval order statement
- CHANGE INVOLVING THE CONJUGATED ANTIBODIES FOR THE DEVICE.
Current openFDA PMA Record#
- Device
- ADVIA CENTAUR PSA & CPSA ASSAYS
- Applicant
- Siemens Healthcare Diagnostics
- PMA number
- P990055
- Supplement
- S011
- Product code
- NAF
- Generic name
- ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA)
- Decision date
- 2009-03-06
- Decision code
- OK30
- Date received
- 2009-02-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE INVOLVING THE CONJUGATED ANTIBODIES FOR THE DEVICE.