PMA P990056S034
- Device
- Elecsys total PSA
- Applicant
- Roche Diagnostics Corp.
- PMA number
- P990056
- Supplement
- S034
- Product code
- MTF
- Decision date
- 2018-10-25
- Classification
- Total, Prostate Specific Antigen (noncomplexed & Complexed) For Detection Of Prostate Cancer
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Approval order statement
- Addition of a raw material supplier.
Current openFDA PMA Record#
- Device
- Elecsys total PSA
- Applicant
- Roche Diagnostics Corp.
- PMA number
- P990056
- Supplement
- S034
- Product code
- MTF
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Decision date
- 2018-10-25
- Decision code
- OK30
- Date received
- 2018-10-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a raw material supplier.