PMA P060005S010
- Device
- IMMULITE 2000 Free PSA
- Applicant
- Siemens Medical Solutions Diagnostics Limited
- PMA number
- P060005
- Supplement
- S010
- Product code
- MTG
- Decision date
- 2019-12-19
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Approval order statement
- Modify the resin used in manufacture of reaction tubes.
Current openFDA PMA Record#
- Device
- IMMULITE 2000 Free PSA
- Applicant
- Siemens Medical Solutions Diagnostics Limited
- PMA number
- P060005
- Supplement
- S010
- Product code
- MTG
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Decision date
- 2019-12-19
- Decision code
- OK30
- Date received
- 2019-11-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modify the resin used in manufacture of reaction tubes.