PMA P890025S009
- Device
- TDX CYCLOSPORINE AND METABOLITES SERUME ASSAY
- Applicant
- Abbott Laboratories
- PMA number
- P890025
- Supplement
- S009
- Product code
- MGU
- Decision date
- 1996-04-01
- Generic name
- Fluorescence polarization immunoassay for cyclosporine
- Approval order statement
- NEW PROBE CLEANING PROCEDURE
Current openFDA PMA Record#
- Device
- TDX CYCLOSPORINE AND METABOLITES SERUME ASSAY
- Applicant
- Abbott Laboratories
- PMA number
- P890025
- Supplement
- S009
- Product code
- MGU
- Generic name
- Fluorescence polarization immunoassay for cyclosporine
- Decision date
- 1996-04-01
- Decision code
- APPR
- Date received
- 1996-01-16
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- NEW PROBE CLEANING PROCEDURE