BAYER IMMUNO 1 SYSTEM
FDA premarket approval P950021/S001 · decided 1999-06-25
Approval details
- PMA number
- P950021
- Supplement
- S001
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- BAYER IMMUNO 1 SYSTEM
- Generic name
- PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
- Applicant
- Siemens Healthcare Diagnostics
- Date received
- 1998-12-22
- Decision date
- 1999-06-25
- Days to decision
- 185 days
- Decision code
- APPR
- Product code
- LTJ
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- East Walpole, MA
- Statement
- Approval for the Bayer Immuno 1(TM) PSA assay. This device is indicated for the measurement of serum PSA in conjunction with digital rectal exam (DRE) as an aid in the detection of prostate cancer in men aged 50 years and older. This assay is further indicated as an aid in the management (monitoring) of prostate cancer patients.
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