BIO-RAD CYCLOSPORINE BY HPLC TEST
FDA premarket approval P880032/S002 · decided 1996-03-01
Approval details
- PMA number
- P880032
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BIO-RAD CYCLOSPORINE BY HPLC TEST
- Generic name
- HIGH PERFORMANCE LIQUID CHROMATOGRAPHY FOR CYCLOSPORINE
- Applicant
- Bio-Rad
- Date received
- 1993-03-16
- Decision date
- 1996-03-01
- Days to decision
- 1081 days
- Decision code
- APPR
- Product code
- MGS
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Hercules, CA
- 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
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