PMA P920031S001
- Device
- EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY
- Applicant
- Dade Behring, Inc.
- PMA number
- P920031
- Supplement
- S001
- Product code
- MKW
- Decision date
- 2000-08-11
- Classification
- Cyclosporine
- Generic name
- CYCLOSPORINE
- Approval order statement
- APPROVAL FOR EMIT(R) CYCLOSPORINE SAMPLE PRETREATMENT REAGENT AND COBAS INTEGRA 700 CYCLOSPORINE.
Current openFDA PMA Record#
- Device
- EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY
- Applicant
- Dade Behring, Inc.
- PMA number
- P920031
- Supplement
- S001
- Product code
- MKW
- Generic name
- CYCLOSPORINE
- Decision date
- 2000-08-11
- Decision code
- APPR
- Date received
- 1999-07-02
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR EMIT(R) CYCLOSPORINE SAMPLE PRETREATMENT REAGENT AND COBAS INTEGRA 700 CYCLOSPORINE.