PMA P920031S003
- Device
- COBAS INTEGRA 400 PLUS CYCLOSPORINE
- Applicant
- Dade Behring, Inc.
- PMA number
- P920031
- Supplement
- S003
- Product code
- MKW
- Decision date
- 2002-07-24
- Classification
- Cyclosporine
- Generic name
- CYCLOSPORINE
- Approval order 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.
Current openFDA PMA Record#
- Device
- COBAS INTEGRA 400 PLUS CYCLOSPORINE
- Applicant
- Dade Behring, Inc.
- PMA number
- P920031
- Supplement
- S003
- Product code
- MKW
- Generic name
- CYCLOSPORINE
- Decision date
- 2002-07-24
- Decision code
- APPR
- Date received
- 2002-05-17
- Supplement type
- Normal 180 Day Track
- Approval order 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.