EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY
FDA premarket approval P920031/S001 · decided 2000-08-11
Approval details
- PMA number
- P920031
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY
- Generic name
- CYCLOSPORINE
- Applicant
- Dade Behring, Inc.
- Date received
- 1999-07-02
- Decision date
- 2000-08-11
- Days to decision
- 406 days
- Decision code
- APPR
- Product code
- MKW
- Advisory committee
- Clinical Toxicology
- Expedited review
- No
- Location
- Newark, DE
- Statement
- APPROVAL FOR EMIT(R) CYCLOSPORINE SAMPLE PRETREATMENT REAGENT AND COBAS INTEGRA 700 CYCLOSPORINE.
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