PMA P990056S043
- Device
- Elecsys total PSA
- Applicant
- Roche Diagnostics Corp.
- PMA number
- P990056
- Supplement
- S043
- Product code
- MTF
- Decision date
- 2024-08-30
- Classification
- Immunology
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Approval order statement
- Expansion of production activities to new fill lines within the same manufacturing site.
Current openFDA PMA Record#
- Device
- Elecsys total PSA
- Applicant
- Roche Diagnostics Corp.
- PMA number
- P990056
- Supplement
- S043
- Product code
- MTF
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Decision date
- 2024-08-30
- Decision code
- OK30
- Date received
- 2024-08-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Expansion of production activities to new fill lines within the same manufacturing site.