PMA P990056S033
- Device
- Elecsys total PSA
- Applicant
- Roche Diagnostics Corp.
- PMA number
- P990056
- Supplement
- S033
- Product code
- MTF
- Decision date
- 2018-06-13
- 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
- Approval for a software update (version 06-05) for the cobas 8000 Modular Analyzer Series
Current openFDA PMA Record#
- Device
- Elecsys total PSA
- Applicant
- Roche Diagnostics Corp.
- PMA number
- P990056
- Supplement
- S033
- Product code
- MTF
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Decision date
- 2018-06-13
- Decision code
- APPR
- Date received
- 2018-04-17
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a software update (version 06-05) for the cobas 8000 Modular Analyzer Series