PMA P930027S025
- Device
- IMMULITE/IMMULITE 1000 THIRD GENERATION PSA
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- PMA number
- P930027
- Supplement
- S025
- Product code
- MTF
- Decision date
- 2021-04-28
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Approval order statement
- Modify resin used in manufacture of test unit cap/body.
Current openFDA PMA Record#
- Device
- IMMULITE/IMMULITE 1000 THIRD GENERATION PSA
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- PMA number
- P930027
- Supplement
- S025
- Product code
- MTF
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Decision date
- 2021-04-28
- Decision code
- OK30
- Date received
- 2021-04-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modify resin used in manufacture of test unit cap/body.