BIO-RAD CYCLOSPORINE BY HPLC TEST
FDA premarket approval P880032/S001 · decided 1991-03-14
Approval details
- PMA number
- P880032
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- BIO-RAD CYCLOSPORINE BY HPLC TEST
- Generic name
- HIGH PERFORMANCE LIQUID CHROMATOGRAPHY FOR CYCLOSPORINE
- Applicant
- Bio-Rad
- Date received
- 1990-12-06
- Decision date
- 1991-03-14
- Days to decision
- 98 days
- Decision code
- APPR
- Product code
- MGS
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Hercules, CA
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