TDX/TDXFLX CYCLOSPORINE AND METABOLITES WHOLE BLOOD; AND CYCLOSPORINE MONOCLONAL WHOLE BLOOD
FDA premarket approval P890025/S014 · decided 2002-09-05
Approval details
- PMA number
- P890025
- Supplement
- S014
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TDX/TDXFLX CYCLOSPORINE AND METABOLITES WHOLE BLOOD; AND CYCLOSPORINE MONOCLONAL WHOLE BLOOD
- Generic name
- Fluorescence polarization immunoassay for cyclosporine
- Applicant
- Abbott Laboratories
- Date received
- 2002-03-18
- Decision date
- 2002-09-05
- Days to decision
- 171 days
- Decision code
- APPR
- Product code
- MGU
- Advisory committee
- Clinical Toxicology
- Expedited review
- No
- Location
- Abbott Park, IL
- Statement
- APPROVAL TO ADD A QUALITY CONTROL TEST WHICH WILL BE PERFORMED AFTER THE REAGENT PACK IS PACKAGED.
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