SANDIMMUNE(R) RADIOIMMUNOASSAY KIT
FDA premarket approval P850086/S001 · decided 1991-12-17
Approval details
- PMA number
- P850086
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SANDIMMUNE(R) RADIOIMMUNOASSAY KIT
- Generic name
- CYCLOSPORINE RADIOIMMUNOASSAY
- Applicant
- Sandoz Pharmaceuticals Corp.
- Date received
- 1990-03-26
- Decision date
- 1991-12-17
- Days to decision
- 631 days
- Decision code
- APPR
- Product code
- LTB
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- E. Hanover, NJ
- Statement
- Approval for a change in the polyclonal antibody to a monoclonal specific and a monoclonal non-specific antibody assay.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.