PMA P950021S017
- Device
- Atellica IM Prostate-Specific Antigen (PSA) Assay
- Applicant
- Siemens Healthcare Diagnostics
- PMA number
- P950021
- Supplement
- S017
- Product code
- MTG
- Decision date
- 2019-03-08
- 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
- Adding an additional manufacturing site for the instrument module.
Current openFDA PMA Record#
- Device
- Atellica IM Prostate-Specific Antigen (PSA) Assay
- Applicant
- Siemens Healthcare Diagnostics
- PMA number
- P950021
- Supplement
- S017
- Product code
- MTG
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Decision date
- 2019-03-08
- Decision code
- OK30
- Date received
- 2019-02-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Adding an additional manufacturing site for the instrument module.