FDA PMA
FDA Class 2
Approved
🇺🇸 United States
Cyclosporine
PMA: P920031
·
Supplement: S001
·
Decision Aug 11, 2000
Classifications
1
FEI Numbers
11
Registration Numbers
11
Basic Information
- Device Name
- Cyclosporine
- Trade Name
- EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY
- PMA Number
- P920031
- Supplement Number
- S001
- Device Class
- FDA Class 2
- Product Code
- MKW
- Generic Name
- CYCLOSPORINE
- Regulation Number
- 862.1235
- Medical Specialty
- Clinical Chemistry
- Advisory Committee
- Clinical Toxicology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- August 11, 2000
- Date Received
- July 2, 1999
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR EMIT(R) CYCLOSPORINE SAMPLE PRETREATMENT REAGENT AND COBAS INTEGRA 700 CYCLOSPORINE.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MKW | Cyclosporine | FDA class 2 | Clinical Chemistry |