IMMULITE / IMMULITE 1000 Third Generation PSA
FDA premarket approval P930027/S018 · decided 2017-10-11
Approval details
- PMA number
- P930027
- Supplement
- S018
- Supplement type
- Special (Immediate Track)
- 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
- 2017-09-15
- Decision date
- 2017-10-11
- Days to decision
- 26 days
- Decision code
- APPR
- Product code
- MTF
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Gwynedd Ll55 4el
- Statement
- Approval for temporary changes to the product quality controls that enhances the safety of IMMULITE® 3rd Generation PSA High Adjustor (LUPH).
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