TDX/TDXFLX CYCLOSPORINE AND METABOLITES WHOLE BLOOD/MONOCLONAL WHOLE BLOOD
FDA premarket approval P890025/S012 · decided 1999-09-29
Approval details
- PMA number
- P890025
- Supplement
- S012
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- TDX/TDXFLX CYCLOSPORINE AND METABOLITES WHOLE BLOOD/MONOCLONAL WHOLE BLOOD
- Generic name
- Fluorescence polarization immunoassay for cyclosporine
- Applicant
- Abbott Laboratories
- Date received
- 1999-09-23
- Decision date
- 1999-09-29
- Days to decision
- 6 days
- Decision code
- APPR
- Product code
- MGU
- Advisory committee
- Clinical Toxicology
- Expedited review
- No
- Location
- Abbott Park, IL
- Statement
- Approval for adding "Caution: This product contains natural dry rubber" to the labeling.
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