PMA P000027S034
- Device
- Elecsys free PSA Test System
- Applicant
- Roche Diagnostics Corp.
- PMA number
- P000027
- Supplement
- S034
- Product code
- MTG
- Decision date
- 2019-05-03
- Classification
- Test, Prostate Specific Antigen, Free, (noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Approval order statement
- Approval for addition of K2-EDTA plasma as an approved sample type for the Elecsys total PSA and Elecsys free PSA test systems.
Current openFDA PMA Record#
- Device
- Elecsys free PSA Test System
- Applicant
- Roche Diagnostics Corp.
- PMA number
- P000027
- Supplement
- S034
- Product code
- MTG
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Decision date
- 2019-05-03
- Decision code
- APPR
- Date received
- 2019-01-29
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for addition of K2-EDTA plasma as an approved sample type for the Elecsys total PSA and Elecsys free PSA test systems.