PMA P920030S001
- Device
- CIBA CORNING ACS PSA IMMUNOASSAY
- Applicant
- Bayer Healthcare, LLC
- PMA number
- P920030
- Supplement
- S001
- Product code
- LTJ
- Decision date
- 1995-12-13
- Generic name
- PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
- Approval order statement
- APPROVAL FOR A CHANGE IN THE METHOD OF STANDARDIZATION OF THE CALIBRATORS FOR THE ASSAY
Current openFDA PMA Record#
- Device
- CIBA CORNING ACS PSA IMMUNOASSAY
- Applicant
- Bayer Healthcare, LLC
- PMA number
- P920030
- Supplement
- S001
- Product code
- LTJ
- Generic name
- PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
- Decision date
- 1995-12-13
- Decision code
- APPR
- Date received
- 1995-09-14
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A CHANGE IN THE METHOD OF STANDARDIZATION OF THE CALIBRATORS FOR THE ASSAY