PMA P060005S009
- Device
- IMMULITE/IMMULITE 1000 Free PSA and IMMULITE 2000 Free PSA
- Applicant
- Siemens Medical Solutions Diagnostics Limited
- PMA number
- P060005
- Supplement
- S009
- Product code
- MTG
- Decision date
- 2018-12-27
- 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 labeling changes describing the impact of endogenous biotin.
Current openFDA PMA Record#
- Device
- IMMULITE/IMMULITE 1000 Free PSA and IMMULITE 2000 Free PSA
- Applicant
- Siemens Medical Solutions Diagnostics Limited
- PMA number
- P060005
- Supplement
- S009
- Product code
- MTG
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Decision date
- 2018-12-27
- Decision code
- APPR
- Date received
- 2018-09-28
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for labeling changes describing the impact of endogenous biotin.