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.
| Device | BIO-RAD CYCLOSPORINE BY HPLC TEST |
| Classification Name | High Performance Liquid Chromatography For Cyclosporine |
| Generic Name | High Performance Liquid Chromatography For Cyclosporine |
| Applicant | Bio-Rad |
| Date Received | 1990-12-06 |
| Decision Date | 1991-03-14 |
| PMA | P880032 |
| Supplement | S001 |
| Product Code | MGS |
| Advisory Committee | Clinical Chemistry |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Bio-Rad 4000 Alfred Nobel Dr. hercules, CA 94547-1803 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P880032 | Original Filing | |
| S002 | 1993-03-16 | Normal 180 Day Track |
| S001 | 1990-12-06 | Normal 180 Day Track |