FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
PMA: P120008
·
Supplement: S007
·
Decision Dec 11, 2014
Classifications
1
FEI Numbers
9
Registration Numbers
9
Basic Information
- Device Name
- Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
- Trade Name
- ARCHITECT AFP
- PMA Number
- P120008
- Supplement Number
- S007
- 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
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- December 11, 2014
- Date Received
- November 13, 2014
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
REMOVAL OF A FUNCTIONAL QUALITY CONTROL TEST METHOD THAT DETECTS STATIC CHARGE IN THE ARCHITECT REACTION VESSEL (RV) USED IN THESE DEVICES.
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 |