TDX CYCLOSPORINE AND METABOLITES SERUME ASSAY
FDA premarket approval P890025/S004 · decided 1992-12-17
Approval details
- PMA number
- P890025
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- TDX CYCLOSPORINE AND METABOLITES SERUME ASSAY
- Generic name
- Fluorescence polarization immunoassay for cyclosporine
- Applicant
- Abbott Laboratories
- Date received
- 1992-10-05
- Decision date
- 1992-12-17
- Days to decision
- 73 days
- Decision code
- APPR
- Product code
- MGU
- Advisory committee
- Clinical Toxicology
- Expedited review
- No
- Location
- Abbott Park, IL
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