PMA P990055S013
- Device
- ADVIA CENTAUR CPSA ASSAY
- Applicant
- Siemens Healthcare Diagnostics
- PMA number
- P990055
- Supplement
- S013
- Product code
- NAF
- Decision date
- 2010-08-30
- Classification
- Antigen(complexed),prostate Specific,(cpsa)
- Generic name
- ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA)
- Approval order statement
- IMPLEMENTATION OF AN AUTOMATED PROCESS FOR MAKING A COMPONENT THAT IS COMMON TO THE PSA AND CPSA ASSAYS.
Current openFDA PMA Record#
- Device
- ADVIA CENTAUR CPSA ASSAY
- Applicant
- Siemens Healthcare Diagnostics
- PMA number
- P990055
- Supplement
- S013
- Product code
- NAF
- Generic name
- ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA)
- Decision date
- 2010-08-30
- Decision code
- OK30
- Date received
- 2010-08-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- IMPLEMENTATION OF AN AUTOMATED PROCESS FOR MAKING A COMPONENT THAT IS COMMON TO THE PSA AND CPSA ASSAYS.