PMA P920031S002
- Device
- COBAS INTEGRA CYCLOSPORINE
- Applicant
- Dade Behring, Inc.
- PMA number
- P920031
- Supplement
- S002
- Product code
- MKW
- Decision date
- 2002-02-26
- Classification
- Cyclosporine
- Generic name
- CYCLOSPORINE
- Approval order statement
- APPROVAL TO EXPAND THE USE OF THE COBAS INTEGRA CYCLOSPORING REAGENT SYSTEM TO THE COBAS INTEGRA 400 AND COBAS INTEGRA 800 ANALYZERS.
Current openFDA PMA Record#
- Device
- COBAS INTEGRA CYCLOSPORINE
- Applicant
- Dade Behring, Inc.
- PMA number
- P920031
- Supplement
- S002
- Product code
- MKW
- Generic name
- CYCLOSPORINE
- Decision date
- 2002-02-26
- Decision code
- APPR
- Date received
- 2002-02-20
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL TO EXPAND THE USE OF THE COBAS INTEGRA CYCLOSPORING REAGENT SYSTEM TO THE COBAS INTEGRA 400 AND COBAS INTEGRA 800 ANALYZERS.