Immulite/Immulite 1000 PSA/Immulite 2000 PSA
FDA premarket approval P930027/S019 · decided 2018-04-16
Approval details
- PMA number
- P930027
- Supplement
- S019
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Immulite/Immulite 1000 PSA/Immulite 2000 PSA
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Date received
- 2018-03-19
- Decision date
- 2018-04-16
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- MTF
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Gwynedd Ll55 4el
- Statement
- Approval for an update to the Instructions for Use (IFU) High-Dose Hook Effect claim on IMMULITE / IMMULITE 1000 and IMMULITE 2000 platforms with values obtained for complex PSA (PSA-ACT) high dose effect.
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