PMA P990055S014
- Device
- ADVIA CENTAUR CPSA ASSAY
- Applicant
- Siemens Healthcare Diagnostics
- PMA number
- P990055
- Supplement
- S014
- Product code
- NAF
- Decision date
- 2012-10-15
- Classification
- Antigen(complexed),prostate Specific,(cpsa)
- Generic name
- ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA)
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT STRATEC BIOMEDICAL SWITZERLAND AG IN BERINGEN, SWITZERLAND.
Current openFDA PMA Record#
- Device
- ADVIA CENTAUR CPSA ASSAY
- Applicant
- Siemens Healthcare Diagnostics
- PMA number
- P990055
- Supplement
- S014
- Product code
- NAF
- Generic name
- ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA)
- Decision date
- 2012-10-15
- Decision code
- APPR
- Date received
- 2012-03-26
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT STRATEC BIOMEDICAL SWITZERLAND AG IN BERINGEN, SWITZERLAND.