PMA P880032S002
- Device
- BIO-RAD CYCLOSPORINE BY HPLC TEST
- Applicant
- Bio-Rad
- PMA number
- P880032
- Supplement
- S002
- Product code
- MGS
- Decision date
- 1996-03-01
- Classification
- High Performance Liquid Chromatography For Cyclosporine
- Generic name
- HIGH PERFORMANCE LIQUID CHROMATOGRAPHY FOR CYCLOSPORINE
- 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
Current openFDA PMA Record#
- Device
- BIO-RAD CYCLOSPORINE BY HPLC TEST
- Applicant
- Bio-Rad
- PMA number
- P880032
- Supplement
- S002
- Product code
- MGS
- Generic name
- HIGH PERFORMANCE LIQUID CHROMATOGRAPHY FOR CYCLOSPORINE
- Decision date
- 1996-03-01
- Decision code
- APPR
- Date received
- 1993-03-16
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- 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