COBAS INTEGRA CYCLOSPORINE
FDA premarket approval P920031/S002 · decided 2002-02-26
Approval details
- PMA number
- P920031
- Supplement
- S002
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- COBAS INTEGRA CYCLOSPORINE
- Generic name
- CYCLOSPORINE
- Applicant
- Dade Behring, Inc.
- Date received
- 2002-02-20
- Decision date
- 2002-02-26
- Days to decision
- 6 days
- Decision code
- APPR
- Product code
- MKW
- Advisory committee
- Clinical Toxicology
- Expedited review
- No
- Location
- Newark, DE
- Statement
- APPROVAL TO EXPAND THE USE OF THE COBAS INTEGRA CYCLOSPORING REAGENT SYSTEM TO THE COBAS INTEGRA 400 AND COBAS INTEGRA 800 ANALYZERS.
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