P2psa
Basic Information
- Device Name
- P2psa
- Trade Name
- ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEM
- PMA Number
- P090026
- Supplement Number
- S005
- Device Class
- FDA Class 3
- Product Code
- OYA
- Generic Name
- P2psa
- Medical Specialty
- Unknown
- Advisory Committee
- Immunology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- March 26, 2013
- Date Received
- January 23, 2013
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
PPROVAL FOR 1) THE CHANGE IN POLYPROPYLENE RESIN USED FOR THEREACTION VESSEL CONTAINER MATERIAL THAT IS USED AS THE CONTAINER FOR THE REACTION IN THE DETERMINATION OF RESULTS FOR ACCESS AFP REAGENTS, ACCESS HYBRITECH PSA REAGENTS, ACCESS HYBRITECH FREE PSA REAGENTS AND ACCESS HYBRITECH P2PSA REAGENTS; 2) THE CHANGE INPOLYPROPYLENE RESIN USED FOR THE REAGENT PACK CONTAINER FOR ACCESS HYBRITECH P2PSA REAGENTS AND 3) THE CHANGE IN POLYPROPYLENE RESIN USED FOR THE BOTTLE CAP FOR ACCESS AFP SAMPLE DILUENT AND ACCESS HYBRITECH PSA SAMPLE DILUENT AND ACCESS SUBSTRATE FOR ACCESS AFP, ACCESS HYBRITECH PSA, ACCESS HYBRITECH FREE PSA AND ACCESS HYBRITECH P2PSA.
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 |