IMX TACROLIMUS II ASSAY
FDA premarket approval P970007 · decided 1997-08-26
Approval details
- PMA number
- P970007
- Trade name
- IMX TACROLIMUS II ASSAY
- Generic name
- ENZYME IMMUNOASSAY, TRACROLIMUS
- Applicant
- Abbott Laboratories
- Date received
- 1997-02-18
- Decision date
- 1997-08-26
- Days to decision
- 189 days
- Decision code
- APRL
- Product code
- MLM
- Advisory committee
- Clinical Toxicology
- Expedited review
- Yes
- Location
- Abbott Park, IL
- Statement
- Approval for the IMx(R) Tacrolimus II Assay. This device is indicated for use as an in-vitro reagent sytemf or the quantitative determination of tacrolimus and some metabolites in human whole blood as an aid in the management of liver allograft patients receiving tacrolimus therapy.
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