PMA P990056S044
- Device
- ELECSYS TOTAL PSA IMMUNOASSAY AND TOTAL PSA CALSET
- Applicant
- Roche Diagnostics Corp.
- PMA number
- P990056
- Supplement
- S044
- Product code
- MTF
- Decision date
- 2025-05-27
- Classification
- Immunology
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Approval order statement
- To add another location for a process within the same establishment.
Current openFDA PMA Record#
- Device
- ELECSYS TOTAL PSA IMMUNOASSAY AND TOTAL PSA CALSET
- Applicant
- Roche Diagnostics Corp.
- PMA number
- P990056
- Supplement
- S044
- Product code
- MTF
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Decision date
- 2025-05-27
- Decision code
- OK30
- Date received
- 2025-04-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- To add another location for a process within the same establishment.