PMA P890025S008
- Device
- TDX CYCLOSPORINE AND METABOLITES SERUME ASSAY
- Applicant
- Abbott Laboratories
- PMA number
- P890025
- Supplement
- S008
- Product code
- MGU
- Decision date
- 1994-03-31
- Generic name
- Fluorescence polarization immunoassay for cyclosporine
Current openFDA PMA Record#
- Device
- TDX CYCLOSPORINE AND METABOLITES SERUME ASSAY
- Applicant
- Abbott Laboratories
- PMA number
- P890025
- Supplement
- S008
- Product code
- MGU
- Generic name
- Fluorescence polarization immunoassay for cyclosporine
- Decision date
- 1994-03-31
- Decision code
- APPR
- Date received
- 1993-08-26
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename