CIBA CORNING ACS PSA IMMUNOASSAY
FDA premarket approval P920030/S001 · decided 1995-12-13
Approval details
- PMA number
- P920030
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CIBA CORNING ACS PSA IMMUNOASSAY
- Generic name
- PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
- Applicant
- Bayer Healthcare, LLC
- Date received
- 1995-09-14
- Decision date
- 1995-12-13
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- LTJ
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Tarrytown, NY
- Statement
- APPROVAL FOR A CHANGE IN THE METHOD OF STANDARDIZATION OF THE CALIBRATORS FOR THE ASSAY
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