PMA P890025

Device: TDX/TDXFLX CYCLOSPORINE AND METABOLITES WHOLE BLOOD; AND CYCLOSPORINE MONOCLONAL WHOLE BLOOD
Applicant: Abbott Laboratories
PMA number: P890025
Supplement: S012
Product code: MGU
Decision date: 2002-09-05
Generic name: Fluorescence polarization immunoassay for cyclosporine
Approval order statement: APPROVAL TO ADD A QUALITY CONTROL TEST WHICH WILL BE PERFORMED AFTER THE REAGENT PACK IS PACKAGED.

Current openFDA PMA Record#

Device: TDX/TDXFLX CYCLOSPORINE AND METABOLITES WHOLE BLOOD; AND CYCLOSPORINE MONOCLONAL WHOLE BLOOD
Applicant: Abbott Laboratories
PMA number: P890025
Supplement: S014
Product code: MGU
Generic name: Fluorescence polarization immunoassay for cyclosporine
Decision date: 2002-09-05
Decision code: APPR
Date received: 2002-03-18
Supplement type: Special (Immediate Track)
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL TO ADD A QUALITY CONTROL TEST WHICH WILL BE PERFORMED AFTER THE REAGENT PACK IS PACKAGED.