PMA P950021S012
- Device
- ADVIA CENTAUR PSA ASSAY
- Applicant
- Siemens Healthcare Diagnostics
- PMA number
- P950021
- Supplement
- S012
- Product code
- MTF
- Decision date
- 2010-08-30
- Classification
- Total, Prostate Specific Antigen (noncomplexed & Complexed) For Detection Of Prostate Cancer
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- 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 PSA ASSAY
- Applicant
- Siemens Healthcare Diagnostics
- PMA number
- P950021
- Supplement
- S012
- Product code
- MTF
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- 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.