|
Device | BIO-RAD CYCLOSPORINE BY HPLC TEST |
Generic Name | HIGH PERFORMANCE LIQUID CHROMATOGRAPHY FOR CYCLOSPORINE |
Regulation Number | 862.1235 |
Applicant | Bio-Rad 4000 ALFRED NOBEL DR. HERCULES, CA 94547-1803 |
PMA Number | P880032 |
Supplement Number | S002 |
Date Received | 03/16/1993 |
Decision Date | 03/01/1996 |
Reclassified Date
|
10/16/2002 |
Product Code |
MGS |
Advisory Committee |
Clinical Chemistry |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement 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 |