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.
Change in manufacturer site of the analytical cartridge from the life science group of bio-rad laboratories located in richmond, ca to the clinical systems division of the diagnostics group of bio-rad laboratories located in hercules, ca. , and changing the vendor of the "clean up" columns for the cyclosporin test by hplc
| 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 | 1993-03-16 |
| Decision Date | 1996-03-01 |
| PMA | P880032 |
| Supplement | S002 |
| Product Code | MGS |
| 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 | 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 |