FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

PMA: P760001 · Decision Jan 13, 1984
Classifications
1
FEI Numbers
9
Registration Numbers
9

Basic Information

Device Name
Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
Trade Name
AFP RIA KIT
PMA Number
P760001
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Approved (Withdrawn)
Decision Code
APWD
Decision Date
January 13, 1984
Date Received
December 16, 1976
Expedited Review
N
Docket Number
84M-0031

Classifications

This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

Product Code Device Name
LOK Kit, Test, Alpha-Fetoprotein For Neural Tube Defects