FDA PMA
FDA Class 3
Approved
🇺🇸 United States
P2psa
PMA: P090026
·
Supplement: S022
·
Decision Dec 21, 2018
Classifications
1
FEI Numbers
1
Registration Numbers
1
Basic Information
- Device Name
- P2psa
- Trade Name
- Access Hybritech p2PSA Reagents on the Access Immunoassay Systems
- PMA Number
- P090026
- Supplement Number
- S022
- Device Class
- FDA Class 3
- Product Code
- OYA
- Generic Name
- P2psa
- Medical Specialty
- Unknown
- Advisory Committee
- Immunology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- December 21, 2018
- Date Received
- September 25, 2018
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
Approval for a modification to the Unicel Dxl Clinical System's reagent pipettor gantry and to the reagent vessel carriage by changing the carriage motor and carriage rail suppliers to simplify the design resulting in improvements to manufacturability, service and assembly and cost reduction.
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 |
|---|---|---|---|
| OYA | P2psa | FDA class 3 | Unknown |