PMA P990056S042
- Device
- Elecsys total PSA Test System
- Applicant
- Roche Diagnostics Corp.
- PMA number
- P990056
- Supplement
- S042
- Product code
- MTF
- Decision date
- 2024-10-17
- Classification
- Immunology
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Approval order statement
- to add 100-count pack size
Current openFDA PMA Record#
- Device
- Elecsys total PSA Test System
- Applicant
- Roche Diagnostics Corp.
- PMA number
- P990056
- Supplement
- S042
- Product code
- MTF
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Decision date
- 2024-10-17
- Decision code
- APPR
- Date received
- 2024-07-19
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to add 100-count pack size