FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
PMA: P790032
·
Supplement: S002
·
Decision Mar 28, 1991
Classifications
1
FEI Numbers
9
Registration Numbers
9
Basic Information
- Device Name
- Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
- Trade Name
- CLINICAL ASSAYS (TM) GAMMADAB(R) [ 125 I ]
- PMA Number
- P790032
- Supplement Number
- S002
- 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
- March 28, 1991
- Date Received
- December 24, 1990
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
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 |