IMMULITE® 1000 Free PSA, IMMULITE® 2000 Free PSA
FDA premarket approval P060005/S015 · decided 2023-08-30
Approval details
- PMA number
- P060005
- Supplement
- S015
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- IMMULITE® 1000 Free PSA, IMMULITE® 2000 Free PSA
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Applicant
- Siemens Medical Solutions Diagnostics Limited
- Date received
- 2022-03-21
- Decision date
- 2023-08-30
- Days to decision
- 527 days
- Decision code
- APPR
- Product code
- MTG
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Gwynedd Ll55
- Statement
- Approval for the change in labeling to include a limitation regarding interference from the drug STRENSIQ.
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