IMMULITE/IMMULITE 1000 THIRD GENERATION PSA
FDA premarket approval P930027/S025 · decided 2021-04-28
Approval details
- PMA number
- P930027
- Supplement
- S025
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- IMMULITE/IMMULITE 1000 THIRD GENERATION PSA
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Date received
- 2021-04-14
- Decision date
- 2021-04-28
- Days to decision
- 14 days
- Decision code
- OK30
- Product code
- MTF
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Gwynedd Ll55 4el
- Statement
- Modify resin used in manufacture of test unit cap/body.
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