IMX TACROLIMUS II
FDA premarket approval P970007/S004 · decided 2002-09-05
Approval details
- PMA number
- P970007
- Supplement
- S004
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- IMX TACROLIMUS II
- Generic name
- ENZYME IMMUNOASSAY, TRACROLIMUS
- Applicant
- Abbott Laboratories
- Date received
- 2001-07-30
- Decision date
- 2002-09-05
- Days to decision
- 402 days
- Decision code
- APPR
- Product code
- MLM
- Advisory committee
- Clinical Toxicology
- Expedited review
- No
- Location
- Abbott Park, IL
- Statement
- APPROVAL FOR THE ADDITION OF TESTING OF MODEL 1 CALIBRATOR TO VERIFY THE PROPER FILLING OF THE CALIBRATOR.
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