FDA PMA
FDA Class 3
Approved
🇺🇸 United States
P2psa
PMA: P090026
·
Supplement: S025
·
Decision Jul 31, 2019
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
- S025
- Device Class
- FDA Class 3
- Product Code
- OYA
- Generic Name
- P2psa
- Medical Specialty
- Unknown
- Advisory Committee
- Immunology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- July 31, 2019
- Date Received
- May 2, 2019
- 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 System Software version 5.5.0 to remove a Y-like command that can result in sample sequencing errors for users who are connected to an automation line.
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 |