PMA P950021S001
- Device
- BAYER IMMUNO 1 SYSTEM
- Applicant
- Siemens Healthcare Diagnostics
- PMA number
- P950021
- Supplement
- S001
- Product code
- LTJ
- Decision date
- 1999-06-25
- Classification
- Prostate-specific Antigen (psa) For Management Of Prostate Cancers
- Generic name
- PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
- Approval order 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.
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf/P950021S001B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- BAYER IMMUNO 1 SYSTEM
- Applicant
- Siemens Healthcare Diagnostics
- PMA number
- P950021
- Supplement
- S001
- Product code
- LTJ
- Generic name
- PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
- Decision date
- 1999-06-25
- Decision code
- APPR
- Date received
- 1998-12-22
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order 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.