FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
PMA: P120008
·
Supplement: S014
·
Decision May 23, 2020
Classifications
1
FEI Numbers
9
Registration Numbers
9
Basic Information
- Device Name
- Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
- Trade Name
- Alinity i AFP
- PMA Number
- P120008
- Supplement Number
- S014
- Device Class
- FDA Class 3
- Product Code
- LOK
- Generic Name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Medical Specialty
- Unknown
- Advisory Committee
- Immunology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- May 23, 2020
- Date Received
- March 16, 2020
- Supplement Type
- Normal 180 Day Track No User Fee
- Supplement Reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Approval for a manufacturing site located at Abbott Laboratories, 1915 Hurd Drive, Irving, Texas 75038, USA for the production of the Alinity i System.
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 |
|---|---|---|---|
| LOK | Kit, Test, Alpha-Fetoprotein For Neural Tube Defects | FDA class 3 | Unknown |