PMA P000027
- Device
- ELECSYS FREE PSA IMMUNOASSAY/CALSET/CALCHECK
- Applicant
- Roche Diagnostics Corp.
- PMA number
- P000027
- Supplement
- S036
- Product code
- LTJ
- Decision date
- 2026-04-29
- Generic name
- PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
- Approval order statement
- manufacturing and testing improvements to the Elecsys Streptavidin (SA)-coated microparticles
Current openFDA PMA Record#
- Device
- ELECSYS FREE PSA IMMUNOASSAY/CALSET/CALCHECK
- Applicant
- Roche Diagnostics Corp.
- PMA number
- P000027
- Supplement
- S045
- Product code
- LTJ
- Generic name
- PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
- Decision date
- 2026-04-29
- Decision code
- OK30
- Date received
- 2026-04-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- manufacturing and testing improvements to the Elecsys Streptavidin (SA)-coated microparticles