PMA P890025S012

Device: TDX/TDXFLX CYCLOSPORINE AND METABOLITES WHOLE BLOOD/MONOCLONAL WHOLE BLOOD
Applicant: Abbott Laboratories
PMA number: P890025
Supplement: S012
Product code: MGU
Decision date: 1999-09-29
Generic name: Fluorescence polarization immunoassay for cyclosporine
Approval order statement: Approval for adding "Caution: This product contains natural dry rubber" to the labeling.

Current openFDA PMA Record

Device: TDX/TDXFLX CYCLOSPORINE AND METABOLITES WHOLE BLOOD/MONOCLONAL WHOLE BLOOD
Applicant: Abbott Laboratories
PMA number: P890025
Supplement: S012
Product code: MGU
Generic name: Fluorescence polarization immunoassay for cyclosporine
Decision date: 1999-09-29
Decision code: APPR
Date received: 1999-09-23
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for adding "Caution: This product contains natural dry rubber" to the labeling.