PMA P930027S022
- Device
- IMMULITE 2000 PSA
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- PMA number
- P930027
- Supplement
- S022
- Product code
- MTF
- Decision date
- 2019-12-19
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Approval order statement
- Modify the resin used in manufacture of reaction tubes.
Current openFDA PMA Record#
- Device
- IMMULITE 2000 PSA
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- PMA number
- P930027
- Supplement
- S022
- Product code
- MTF
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- 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.