COBAS INTEGRA 400 PLUS CYCLOSPORINE
FDA premarket approval P920031/S003 · decided 2002-07-24
Approval details
- PMA number
- P920031
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Trade name
- COBAS INTEGRA 400 PLUS CYCLOSPORINE
- Generic name
- CYCLOSPORINE
- Applicant
- Dade Behring, Inc.
- Date received
- 2002-05-17
- Decision date
- 2002-07-24
- Days to decision
- 68 days
- Decision code
- APPR
- Product code
- MKW
- Advisory committee
- Clinical Toxicology
- Expedited review
- No
- Location
- Newark, DE
- Statement
- APPROVAL FOR EXPANDING THE USE OF THE COBAS INTEGRA CYCLOSPORINE REAGENT TO THE COBAS INTEGRA 400 PLUS ANALYZER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME COBAS INTEGRA CYCLOSPORINE AND IS INDICATED FOR QUANTITATIVE DETERMINATION OF CYCLOSPORINE IN WHOLE BLOOD AS AN AID IN THE MANAGEMENT OF CYCLOSPORINE THERAPY IN KIDNEY, HEART AND LIVER TRANSPLANT PATIENTS.
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