PMA P890025S013
- Device
- TDX/TDXFLX CYCLOSPORINE/METABOLITES WHOLE BLOOD
- Applicant
- Abbott Laboratories
- PMA number
- P890025
- Supplement
- S013
- Product code
- MGU
- Decision date
- 2002-09-05
- Classification
- Clinical Toxicology
- Generic name
- Fluorescence polarization immunoassay for cyclosporine
- Approval order statement
- APPROVAL TO PLACE INTO EFFECT THE UPDATED QUALITY CONTROL TEST FOR EVALUATING SHEEP ANTISERUM.
Current openFDA PMA Record#
- Device
- TDX/TDXFLX CYCLOSPORINE/METABOLITES WHOLE BLOOD
- Applicant
- Abbott Laboratories
- PMA number
- P890025
- Supplement
- S013
- Product code
- MGU
- Generic name
- Fluorescence polarization immunoassay for cyclosporine
- Decision date
- 2002-09-05
- Decision code
- APPR
- Date received
- 2001-06-25
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL TO PLACE INTO EFFECT THE UPDATED QUALITY CONTROL TEST FOR EVALUATING SHEEP ANTISERUM.