IMMULITE PSA CATALOG # LKPS1,5)
FDA premarket approval P930027/S003 · decided 1998-05-08
Approval details
- PMA number
- P930027
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- IMMULITE PSA CATALOG # LKPS1,5)
- Generic name
- PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Date received
- 1998-02-20
- Decision date
- 1998-05-08
- Days to decision
- 77 days
- Decision code
- APPR
- Product code
- LTJ
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Gwynedd Ll55 4el
- Statement
- Approval for adding information on the percentage for each PSA range for healthy male subjects as one group in the expected value section.
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