PMA P850086S001
- Device
- SANDIMMUNE(R) RADIOIMMUNOASSAY KIT
- Applicant
- Sandoz Pharmaceuticals Corp.
- PMA number
- P850086
- Supplement
- S001
- Product code
- LTB
- Decision date
- 1991-12-17
- Generic name
- CYCLOSPORINE RADIOIMMUNOASSAY
- Approval order statement
- Approval for a change in the polyclonal antibody to a monoclonal specific and a monoclonal non-specific antibody assay.
Current openFDA PMA Record#
- Device
- SANDIMMUNE(R) RADIOIMMUNOASSAY KIT
- Applicant
- Sandoz Pharmaceuticals Corp.
- PMA number
- P850086
- Supplement
- S001
- Product code
- LTB
- Generic name
- CYCLOSPORINE RADIOIMMUNOASSAY
- Decision date
- 1991-12-17
- Decision code
- APPR
- Date received
- 1990-03-26
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a change in the polyclonal antibody to a monoclonal specific and a monoclonal non-specific antibody assay.