This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Approval for a change in the polyclonal antibody to a monoclonal specific and a monoclonal non-specific antibody assay.
| Device | SANDIMMUNE(R) RADIOIMMUNOASSAY KIT |
| Generic Name | Cyclosporine Radioimmunoassay |
| Applicant | SANDOZ PHARMACEUTICALS CORP. |
| Date Received | 1990-03-26 |
| Decision Date | 1991-12-17 |
| PMA | P850086 |
| Supplement | S001 |
| Product Code | LTB |
| Advisory Committee | Clinical Chemistry |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | SANDOZ PHARMACEUTICALS CORP. rte 10 e. Hanover, NJ 07936 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P850086 | Original Filing | |
| S001 | 1990-03-26 | Normal 180 Day Track |