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TD CYCLOSPORINE AND METABOLITES SERUM ASSAY

FDA premarket approval P890025 · decided 1989-12-14

Approval details

PMA number
P890025
Trade name
TD CYCLOSPORINE AND METABOLITES SERUM ASSAY
Generic name
Fluorescence polarization immunoassay for cyclosporine
Applicant
Abbott Laboratories
Date received
1989-04-10
Decision date
1989-12-14
Days to decision
248 days
Decision code
APRL
Product code
MGU
Advisory committee
Clinical Toxicology
Expedited review
No
Location
Abbott Park, IL

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