TDX/TDXFLX CYCLOSPORINE/METABOLITES WHOLE BLOOD
FDA premarket approval P890025/S013 · decided 2002-09-05
Approval details
- PMA number
- P890025
- Supplement
- S013
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TDX/TDXFLX CYCLOSPORINE/METABOLITES WHOLE BLOOD
- Generic name
- Fluorescence polarization immunoassay for cyclosporine
- Applicant
- Abbott Laboratories
- Date received
- 2001-06-25
- Decision date
- 2002-09-05
- Days to decision
- 437 days
- Decision code
- APPR
- Product code
- MGU
- Advisory committee
- Clinical Toxicology
- Expedited review
- No
- Location
- Abbott Park, IL
- Statement
- APPROVAL TO PLACE INTO EFFECT THE UPDATED QUALITY CONTROL TEST FOR EVALUATING SHEEP ANTISERUM.
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