PMA P990056S028
- Device
- Elecsys total PSA and total PSA CalSet II
- Applicant
- Roche Diagnostics Corp.
- PMA number
- P990056
- Supplement
- S028
- Product code
- MTF
- Decision date
- 2018-07-09
- 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 the migration of Elecsys total PSA and total PSA CalSet II on the cobas e 801 immunoassay analyzer.
Current openFDA PMA Record#
- Device
- Elecsys total PSA and total PSA CalSet II
- Applicant
- Roche Diagnostics Corp.
- PMA number
- P990056
- Supplement
- S028
- Product code
- MTF
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Decision date
- 2018-07-09
- Decision code
- APPR
- Date received
- 2017-07-31
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the migration of Elecsys total PSA and total PSA CalSet II on the cobas e 801 immunoassay analyzer.